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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02951052
Registration number
NCT02951052
Ethics application status
Date submitted
15/09/2016
Date registered
1/11/2016
Date last updated
14/02/2024
Titles & IDs
Public title
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
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Scientific title
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed
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Secondary ID [1]
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2016-001647-39
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Secondary ID [2]
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201585
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infection, Human Immunodeficiency Virus
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HIV Infections
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cabotegravir (CAB) tablet
Treatment: Drugs - Rilpivirine (RPV) tablet
Treatment: Drugs - Cabotegravir - Injectable Suspension (CAB LA)
Treatment: Drugs - Rilpivirine - Injectable Suspension (RPV LA)
Treatment: Drugs - 2 NRTIs plus an INI, NNRTI, or PI
Experimental: CAB LA + RPV LA every 4 weeks - Eligible subjects receive Oral CAB 30 mg + RPV 25 mg once daily for four weeks, IM CAB LA 600 mg and RPV LA 900 mg for the first injection, and Week 4 onwards subjects will receive CAB LA (400 mg) + RPV LA (600 mg) injections every 4 weeks until withdrawal.
Active Comparator: Current antiretroviral regimen - Eligible subjects will continue their current anti-retroviral regimen (2 NRTIs plus an INI, NNRTI, or a PI) for 52 weeks. After 52 weeks subjects have the option to continue study participation by switching to CAB LA + RPV LA in the Extension Phase where they will follow the procedure of CAB LA + RPV LA arm.
Treatment: Drugs: Cabotegravir (CAB) tablet
It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat
Treatment: Drugs: Rilpivirine (RPV) tablet
It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose
Treatment: Drugs: Cabotegravir - Injectable Suspension (CAB LA)
It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection
Treatment: Drugs: Rilpivirine - Injectable Suspension (RPV LA)
It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
Treatment: Drugs: 2 NRTIs plus an INI, NNRTI, or PI
Acceptable stable (initial or second) ARV regimens include 2 NRTIs plus:
INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen)
NNRTI (either the initial or second cART regimen)
Boosted PI (or atazanavir [ATV] unboosted) (either the initial or second PI-based cART regimen)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48
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Assessment method [1]
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Number of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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Number of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48
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Assessment method [1]
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Plasma samples were collected for quantitative analysis of HIV-1 RNA. Number of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48
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Assessment method [2]
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Number of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART.
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Timepoint [2]
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Week 48
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Secondary outcome [3]
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Number of Participants With Confirmed Virologic Failure (CVF)
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Assessment method [3]
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The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL. The outcome displays only visits during which at least one new CVF occurs. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
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Timepoint [3]
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Weeks 8, 12, 20, 24, 32 and 40
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Secondary outcome [4]
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Absolute Values for Plasma HIV-1 RNA at Week 48
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Assessment method [4]
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Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Change From Baseline Values for Plasma HIV-1 RNA
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Assessment method [5]
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Plasma for quantitative HIV-1 RNA were collected at indicated time points. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 - HIV-1 RNA(log 10) at Baseline.
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Timepoint [5]
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Baseline and Week 48
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Secondary outcome [6]
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Absolute Values for CD4+ Lymphocyte Count at Week 48
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Assessment method [6]
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Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.
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Timepoint [6]
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Week 48
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Secondary outcome [7]
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Change From Baseline Values for CD4+ Lymphocyte Count at Week 48
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Assessment method [7]
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Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value at Week 48 minus Baseline value.
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Timepoint [7]
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Baseline (Day 1) and Week 48
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Secondary outcome [8]
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Number of Participants With Disease Progression
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Assessment method [8]
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Disease progression was defined as HIV-associated conditions, acquired immunodeficiency syndrome (AIDS), and death through 48 Weeks. Data of participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented.
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Timepoint [8]
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Up to Week 48
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Secondary outcome [9]
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Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
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Assessment method [9]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of IP during the maintenance phase of the study (on or after Day 1 visit). Participants will be assessed according to actual treatment received.
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Timepoint [9]
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Up to Week 48
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Secondary outcome [10]
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Number of Participants With Severity of Adverse Events
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Assessment method [10]
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Severity of adverse events (AEs) were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.
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Timepoint [10]
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Up to Week 48
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Secondary outcome [11]
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Absolute Values for Hematology Parameters Over Time Including Week 48: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
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Assessment method [11]
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Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.
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Timepoint [11]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [12]
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Absolute Values for Hematology Parameters: Erythrocyte Mean Corpuscular Volume
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Assessment method [12]
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Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated time points.
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Timepoint [12]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [13]
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Absolute Values for Hematology Parameters: Erythrocytes
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Assessment method [13]
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Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated time points.
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Timepoint [13]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [14]
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Absolute Values for Hematology Parameters: Hemoglobin
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Assessment method [14]
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Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points.
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Timepoint [14]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [15]
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Absolute Values for Hematology Parameters: Hematocrit
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Assessment method [15]
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Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated time points.
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Timepoint [15]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [16]
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Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
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Assessment method [16]
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Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
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Timepoint [16]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [17]
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Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume
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Assessment method [17]
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Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
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Timepoint [17]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [18]
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Change From Baseline for Hematology Parameters: Erythrocytes
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Assessment method [18]
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Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
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Timepoint [18]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [19]
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Change From Baseline for Hematology Parameters: Hematocrit
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Assessment method [19]
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Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
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Timepoint [19]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [20]
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Change From Baseline for Hematology Parameters: Hemoglobin
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Assessment method [20]
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Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
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Timepoint [20]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [21]
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Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK)
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Assessment method [21]
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Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points.
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Timepoint [21]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [22]
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Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
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Assessment method [22]
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Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated time points.
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Timepoint [22]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [23]
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Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
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Assessment method [23]
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Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated time points.
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Timepoint [23]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [24]
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Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48
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Assessment method [24]
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Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated time points.
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Timepoint [24]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [25]
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Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
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Assessment method [25]
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Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated time points.
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Timepoint [25]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [26]
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Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance
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Assessment method [26]
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Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
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Timepoint [26]
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Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [27]
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Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48
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Assessment method [27]
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The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to Division of AIDS (DAIDS) scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.
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Timepoint [27]
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Baseline (Day 1) and at Weeks 4, 24 and 48.
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Secondary outcome [28]
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Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48
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Assessment method [28]
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Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
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Timepoint [28]
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Baseline (Day 1) and at Weeks 4, 24 and 48
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Secondary outcome [29]
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Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK
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Assessment method [29]
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Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [29]
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0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [30]
0
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Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
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Assessment method [30]
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Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [30]
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0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [31]
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Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
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Assessment method [31]
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Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [31]
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0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [32]
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0
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48
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Assessment method [32]
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Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [32]
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0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [33]
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0
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
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Assessment method [33]
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Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [33]
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0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [34]
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Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance.
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Assessment method [34]
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Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [34]
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0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
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Secondary outcome [35]
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Change From Baseline Values for Fasting Lipid Panel Over Time Including Week 48
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Assessment method [35]
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Blood samples were collected for the analysis of fasting lipid parameters- total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [35]
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0
Baseline (Day 1) and at Week 48
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Secondary outcome [36]
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Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48
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Assessment method [36]
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Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [36]
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0
Baseline (Day 1) and at Weeks 4, 24 and 48
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Secondary outcome [37]
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Change From Baseline Values in Urine Creatinine Over Time Including Week 48
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Assessment method [37]
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Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [37]
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0
Baseline (Day 1) and at Weeks 4, 24 and 48
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Secondary outcome [38]
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Change From Baseline Values in Urine Phosphate Over Time Including Week 48
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Assessment method [38]
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Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [38]
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0
Baseline (Day 1) and at Weeks 4, 24 and 48
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Secondary outcome [39]
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Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48
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Assessment method [39]
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Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [39]
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0
Baseline (Day 1) and at Week 48
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Secondary outcome [40]
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Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48
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Assessment method [40]
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Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.
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Timepoint [40]
0
0
Baseline (Day 1) and at Weeks 4, 24 and 48
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Secondary outcome [41]
0
0
Change From Baseline Values in Urine pH Over Time Including Week 48
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Assessment method [41]
0
0
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [41]
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0
Baseline (Day 1) and at Weeks 4, 24 and 48
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Secondary outcome [42]
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Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48
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Assessment method [42]
0
0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Query!
Timepoint [42]
0
0
Up to Week 48
Query!
Secondary outcome [43]
0
0
Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48
Query!
Assessment method [43]
0
0
Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Percentage change from Baseline is calculated as: value at Week 48 minus Baseline value divided by Baseline value multiplied by 100.
Query!
Timepoint [43]
0
0
Baseline (Day 1) and at Week 48
Query!
Secondary outcome [44]
0
0
Number of Participants With Phenotypic Resistance Through Week 48
Query!
Assessment method [44]
0
0
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.The CVF population comprised of all participants in ITT-E population who met CVF criteria.Phenotypic Resistance data for following drugs:CAB,dolutegravir(DTG),elvitegravir(EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI), atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),rito-navir(RTV),saquinavir(SQV) and tipranavir(TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance(FC>clinical higher cutoff/biologic cutoff),partially sensitive(FC <=clinical higher cutoff and > clinical lower cutoff),sensitive(FC <= clinical lower cutoff/biologic cutoff).
Query!
Timepoint [44]
0
0
At the time of CVF
Query!
Secondary outcome [45]
0
0
Number of Participants With Genotypic Resistance Through Week 48
Query!
Assessment method [45]
0
0
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.
Query!
Timepoint [45]
0
0
At the time of CVF
Query!
Secondary outcome [46]
0
0
Number of Participants With AEs by Using Baseline Third Agent Treatment Class Overtime Including Week 48
Query!
Assessment method [46]
0
0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Query!
Timepoint [46]
0
0
Up to Week 48
Query!
Secondary outcome [47]
0
0
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK
Query!
Assessment method [47]
0
0
Blood samples were collected for the analysis of clinical chemistry parameters to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Query!
Timepoint [47]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [48]
0
0
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin
Query!
Assessment method [48]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Query!
Timepoint [48]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [49]
0
0
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Query!
Assessment method [49]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Query!
Timepoint [49]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [50]
0
0
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance
Query!
Assessment method [50]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI.
Query!
Timepoint [50]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [51]
0
0
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase
Query!
Assessment method [51]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Query!
Timepoint [51]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [52]
0
0
Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48
Query!
Assessment method [52]
0
0
Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Query!
Timepoint [52]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [53]
0
0
Absolute Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48
Query!
Assessment method [53]
0
0
Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).
Query!
Timepoint [53]
0
0
Baseline (Day 1) and at Week 48
Query!
Secondary outcome [54]
0
0
Number of Participants Discontinued or Withdrawn Due to AEs When Baseline Third Agent Treatment Class Was Used Over Time Including Week 48
Query!
Assessment method [54]
0
0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Query!
Timepoint [54]
0
0
Up to Week 48
Query!
Secondary outcome [55]
0
0
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Query!
Assessment method [55]
0
0
Blood samples will be collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK population includes all participants who received CAB and / or RPV and underwent PK sampling during the study, and provided CAB and /or RPV plasma concentration data.
Query!
Timepoint [55]
0
0
Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [56]
0
0
Ctrough for RPV LA Evaluable
Query!
Assessment method [56]
0
0
Blood samples will be collected at indicated time points for PK analysis of RPV LA.
Query!
Timepoint [56]
0
0
Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [57]
0
0
Area Under the Curve (AUC) for CAB LA
Query!
Assessment method [57]
0
0
AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for CAB LA.
Query!
Timepoint [57]
0
0
Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41
Query!
Secondary outcome [58]
0
0
AUC for RPV LA
Query!
Assessment method [58]
0
0
AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for RPV LA.
Query!
Timepoint [58]
0
0
Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41
Query!
Secondary outcome [59]
0
0
Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41
Query!
Assessment method [59]
0
0
Blood samples will be collected at indicated time points for PK analysis of CAB LA.
Query!
Timepoint [59]
0
0
Week 41- 1 Week post dose
Query!
Secondary outcome [60]
0
0
Cmax in Plasma for RPV LA Evaluable at Week 41
Query!
Assessment method [60]
0
0
Blood samples will be collected at indicated time points for PK analysis of RPV LA.
Query!
Timepoint [60]
0
0
Week 41- 1 Week post dose
Query!
Secondary outcome [61]
0
0
Percentage of Participants With a Virologic Failure Using Snapshot Algorithm by Baseline Third Agent
Query!
Assessment method [61]
0
0
Percentage of participants with virologic failure endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA >=50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.
Query!
Timepoint [61]
0
0
Week 48
Query!
Secondary outcome [62]
0
0
Percentage of Participants With Plasma HIV-1 RNA <50copies/mL Using Snapshot Algorithm by Baseline Third Agent
Query!
Assessment method [62]
0
0
Percentage of participants with HIV-1 RNA < 50copies/mL endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA <50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.
Query!
Timepoint [62]
0
0
Week 48
Query!
Secondary outcome [63]
0
0
Number of Participants With Severity of Adverse Events by Baseline Third Agents
Query!
Assessment method [63]
0
0
Severity of AEs were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.
Query!
Timepoint [63]
0
0
Up to Week 48
Query!
Secondary outcome [64]
0
0
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK
Query!
Assessment method [64]
0
0
Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST and CK to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [64]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [65]
0
0
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin
Query!
Assessment method [65]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [65]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [66]
0
0
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Query!
Assessment method [66]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [66]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [67]
0
0
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance
Query!
Assessment method [67]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [67]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [68]
0
0
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase
Query!
Assessment method [68]
0
0
Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [68]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [69]
0
0
Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48
Query!
Assessment method [69]
0
0
Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [69]
0
0
Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Query!
Secondary outcome [70]
0
0
Change From Baseline Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48
Query!
Assessment method [70]
0
0
Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [70]
0
0
Baseline (Day 1) and at Week 48
Query!
Secondary outcome [71]
0
0
Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48
Query!
Assessment method [71]
0
0
Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.
Query!
Timepoint [71]
0
0
At the time of CVF
Query!
Secondary outcome [72]
0
0
Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48
Query!
Assessment method [72]
0
0
Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Phenotypic Resistance data for the following drugs: CAB, DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. Phenotypic resistance, partially sensitive, and Sensitive were defined based on FC value from Monogram as: resistance (FC>clinical higher cutoff/biologic cutoff), partially sensitive (FC <=clinical higher cutoff and > clinical lower cutoff), sensitive (FC <= clinical lower cutoff/biologic cutoff).
Query!
Timepoint [72]
0
0
At the time of CVF
Query!
Secondary outcome [73]
0
0
Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm
Query!
Assessment method [73]
0
0
The PIN questionnaire explores the bother of pain at the injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCFwas used as primary method of analysis
Query!
Timepoint [73]
0
0
Week 5 and at Weeks 41 and 48
Query!
Secondary outcome [74]
0
0
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm
Query!
Assessment method [74]
0
0
The PIN questionnaire explores the bother of pain at the injection site and injection site reactions(ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCF was used as primary method of analysis
Query!
Timepoint [74]
0
0
Weeks 5, 41 and 48
Query!
Secondary outcome [75]
0
0
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire
Query!
Assessment method [75]
0
0
The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% confidence interval (CI).Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [75]
0
0
Baseline (Day 1) and at Weeks 24 and 48
Query!
Secondary outcome [76]
0
0
Change From Baseline in HIV Medication, MEDWO Using HATQoL
Query!
Assessment method [76]
0
0
The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=[100 divided by (20 minus 5)]*(MEDWO minus 5). A response of 1 in MEDWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [76]
0
0
Baseline and at Weeks 24 and 48
Query!
Secondary outcome [77]
0
0
Change From Baseline in DISWO Using HATQoL
Query!
Assessment method [77]
0
0
The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=[100 divided by (20 minus 5)]*(DISWO minus 5). A response of 1 in DISWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [77]
0
0
Baseline and at Weeks 24 and 48
Query!
Secondary outcome [78]
0
0
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12)
Query!
Assessment method [78]
0
0
The SF-12 questionnaire consists of 7 questions which measures the degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. The HRQoL using SF-12 for the total score, physical component summary (PCS) and the mental component summary (MCS) were assessed for the two treatment groups. Missing Total or the component scores was imputed using LOCF. The PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com). The higher the score, the better will be the health status. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [78]
0
0
Baseline and at Weeks 24 and 48
Query!
Secondary outcome [79]
0
0
Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44
Query!
Assessment method [79]
0
0
The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants
Query!
Timepoint [79]
0
0
Baseline and at Weeks 4b, 24 and 44
Query!
Secondary outcome [80]
0
0
Change in Treatment Satisfaction Over Time Using HIVTSQ Change (HIVTSQc) at Week 48 in Q4W Arm
Query!
Assessment method [80]
0
0
The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants
Query!
Timepoint [80]
0
0
Week 48
Query!
Secondary outcome [81]
0
0
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire
Query!
Assessment method [81]
0
0
The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication will be analyzed.Items on the scale are rated as 1-5 scores:1:totally disagree,2:somewhat disagree,3:somewhat agree, 4:totally agree and 5:I don't know.Total score of the dimension is calculated as the mean of the recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:score:Total Score=(mean of the recoded items in the dimension minus1)divided by2*100.LOCF was used as primary method of analysis.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI.Baseline value is defined as the latest pre-treatment assessment with a non-missing value.Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value
Query!
Timepoint [81]
0
0
Baseline and at Weeks 8, 24 and 48
Query!
Secondary outcome [82]
0
0
Change From 4b in Tolerability of Injection at Week 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm
Query!
Assessment method [82]
0
0
The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.
Query!
Timepoint [82]
0
0
Weeks 4b, 5, 40 and 41
Query!
Secondary outcome [83]
0
0
Change From Baseline in Individual Item Scores of HIVTSQc at Weeks 4b, 24 and 44
Query!
Assessment method [83]
0
0
HIVTSQc is a 12 item questionnaire. The individual treatment change item scores on HIVTSQc scale are rated as +3 ('much more satisfied', 'much more convenient', 'much more flexible',etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). The higher the score, the greater the improvement in satisfaction with each aspect of treatment and the lower the score, the greater the deterioration in satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Query!
Timepoint [83]
0
0
Baseline and Weeks 4b, 24 and 44
Query!
Eligibility
Key inclusion criteria
- Aged 18 years or older (or =19 where required by local regulatory agencies), at the
time of signing the informed consent.
- Must be on uninterrupted current regimen (either the initial or second ARV regimen)
for at least 6 months prior to Screening. Any prior switch, defined as a change of a
single drug or multiple drugs simultaneously, must have occurred due to
tolerability/safety, access to medications, or convenience/simplification, and must
NOT have been done for treatment failure (HIV-1 RNA =400 c/mL).
- Acceptable stable (initial or second) ARV regimens prior to Screening include 2 NRTIs
plus: INI with the exception of ABC/DTG/3TC (either the initial or second cART
regimen);NNRTI (either the initial or second cART regimen);Boosted PI (or atazanavir
[ATV] unboosted) (must be either the initial cART regimen or one historical within
class switch is permitted due to safety/tolerability) The addition, removal, or switch
of a drug(s) that has been used to treat HIV based on antiretroviral properties of the
drug constitutes a change in ART with the following limited exceptions: Historical
changes in formulations of ART drugs or booster drugs will not constitute a change in
ART regimen if the data support similar exposures and efficacy, and the change must
have been at least 3 months prior to Screening; Historical perinatal use of an NRTI
when given in addition to an ongoing HAART will not be considered a change in ART
regimen; A change in dosing scheme of the same drug from twice daily to once daily
will not be considered a change in ART regimen if data support similar exposures and
efficacy.
- Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12
months prior to Screening: one within the 6 to 12 month window, and one within 6
months prior to Screening;
- Plasma HIV-1 RNA <50 c/mL at Screening;
- A female subjects is eligible to participate if she is not pregnant (as confirmed by a
negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine
hCG test at Randomization), not lactating, and at least one of the following
conditions applies:
1. Non-reproductive potential defined as: Pre-menopausal females with one of the
following: Documented tubal ligation; Documented hysteroscopic tubal occlusion
procedure with follow-up; confirmation of bilateral tubal occlusion;
Hysterectomy; Documented Bilateral Oophorectomy; Postmenopausal defined as 12
months of spontaneous amenorrhea [in questionable cases a blood sample with
simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent
with menopause. Females on hormone replacement therapy (HRT) and whose menopausal
status is in doubt will be required to use one of the highly effective
contraception methods if they wish to continue their HRT during the study.
Otherwise, they must discontinue HRT to allow confirmation of post-menopausal
status prior to study enrolment.
2. Reproductive potential and agrees to the options listed in the Modified List of
Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive
Potential (FRP) from 30 days prior to the first dose of study medication, and
until from 30 days prior to the first dose of study medication throughout the
study, and for at least 30 days after discontinuation of all oral study
medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
The investigator is responsible for ensuring that subjects understand how to
properly use these methods of contraception.
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the consent form. Eligible subjects or their
legal guardians (and next of kin when locally required), must sign a written Informed
Consent Form before any protocol-specified assessments are conducted. Enrolment of
subjects who are unable to provide direct informed consent is optional and will be
based on local legal/regulatory requirements and site feasibility to conduct protocol
procedures.
- Subjects enrolled in France must be affiliated to, or a beneficiary of, a social
security category.
- All subjects participating in the study should be counselled on safer sexual practices
including the use and benefit/risk of effective barrier methods (e.g., male condom)
and on the risk of HIV transmission to an uninfected partner.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on
current ART regimen, any plasma HIV-1 RNA measurement =50 c/mL
- Within the 6 to 12 month window prior to Screening and after confirmed suppression to
<50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA
measurements =50 c/mL
- Any drug holiday during the window between initiating first HIV ART and 6 months prior
to Screening, except for brief periods (less than 1 month) where all ART was stopped
due to tolerability and/or safety concerns
- Any switch to a second line regimen, defined as change of a single drug or multiple
drugs simultaneously, due to virologic failure to therapy (defined as a confirmed
plasma HIV-1 RNA measurement =400 c/mL after initial suppression to <50 c/mL while on
first line HIV therapy regimen)
- Abacavir/dolutegravir/lamivudine, (ABC/DTG/3TC) as current ART regimen
- A history of use of any regimen consisting of only single NNRTI therapy (even if only
for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART
- Subjects who are currently participating in or anticipate to be selected for any other
interventional study
- Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during
the study
- Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3
disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy
and historical or current CD4 cell counts less than 200 cells/mm^3
- Subjects with moderate to severe hepatic impairment
- Any pre-existing physical or mental condition (including substance use disorder)
which, in the opinion of the Investigator, may interfere with the subjects ability to
comply with the dosing schedule and/or protocol evaluations or which may compromise
the safety of the subject.
- Subjects determined by the Investigator to have a high risk of seizures, including
subjects with an unstable or poorly controlled seizure disorder. A subject with a
prior history of seizure may be considered for enrolment if the Investigator believes
the risk of seizure recurrence is low. All cases of prior seizure history should be
discussed with the Medical Monitor prior to enrolment
- All subjects will be screened for syphilis (rapid plasma reagin [RPR]). Subjects with
untreated syphilis infection, defined as a positive RPR without clear documentation of
treatment, are excluded. Subjects with a serofast RPR result (persistence of a
reactive nontreponemal syphilis test) despite history of adequate therapy and no
evidence of re-exposure may enrol after consultation with the Medical Monitor.
Subjects with a positive RPR test who have not been treated may be rescreened at least
30 days after completion of antibiotic treatment for syphilis
- Subjects who, in the investigator's judgment, pose a significant suicide risk.
Subject's recent history of suicidal behavior and/or suicidal ideation should be
considered when evaluating for suicide risk
- The subject has a tattoo or other dermatological condition overlying the gluteus
region which may interfere with interpretation of injection site reactions
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at
Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody
(anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:•Subjects
positive for HBsAg are excluded;
- Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and
positive for HBV DNA are excluded
- Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be
excluded, however Investigators must carefully assess if therapy specific for HCV
infection is required; subjects who are anticipated to require HCV treatment within 12
months must be excluded. (HCV treatment on study may be permitted post Week 48,
following consultation with the medical monitor) Subjects with HCV co-infection will
be allowed entry into phase 3 studies if: Liver enzymes meet entry criteria; HCV
Disease has undergone appropriate work-up, and is not advanced, and will not require
treatment prior to the Week 48 visit. Additional information (where available) on
subjects with HCV co-infection at screening should include results from any liver
biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or
other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
In the event that recent biopsy or imaging data is not available or inconclusive, the
Fib-4 score will be used to verify eligibility: Fib-4 score > 3.25 is exclusionary;
Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score
Formula:( Age x AST ) / ( Platelets x ( sqr [ ALT ])
- Unstable liver disease (as defined by any of the following: presence of
ascites,encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric
varices,or persistent jaundice or cirrhosis), known biliary abnormalities (with the
exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic
liver disease per investigator assessment)
- History of liver cirrhosis with or without hepatitis viral co-infection.
- Ongoing or clinically relevant pancreatitis
- Clinically significant cardiovascular disease, as defined by history/evidence of
congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery
bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty
(PTCA) or any clinically significant cardiac disease
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or
resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial
neoplasia; other localized malignancies require agreement between the investigator and
the Study medical monitor for inclusion of the subject prior to randomization
- Any condition which, in the opinion of the Investigator, may interfere with the
absorption, distribution, metabolism or excretion of the study drugs or render the
subject unable to receive study medication
- History or presence of allergy or intolerance to the study drugs or their components
or drugs of their class. In addition, if heparin is used during PK sampling, subjects
with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not
be enrolled
- Current or anticipated need for chronic anti-coagulation with the exception of the use
of low dose acetylsalicylic acid (=325mg).
- Any evidence of primary resistance based on the presence of any major known INI or
NNRTI resistance-associated mutation, except for K103N, (International AIDS Society
[IAS]-USA, 2015) by any historical resistance test result.
- Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during
the Screening phase to verify a result
- Any acute laboratory abnormality at Screening, which, in the opinion of the
investigator, would preclude the subject's participation in the study of an
investigational compound
- Subject has estimated creatine clearance <50mL/min per 1.73m^2 via CKDEPI Method
- Alanine aminotransferase (ALT) =3 × ULN Exposure to an experimental drug or
experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice
the duration of the biological effect of the test agent, whichever is longer, prior to
Day 1 of this study;
- Treatment with any of the following agents within 28 days of Screening: radiation
therapy; cytotoxic chemotherapeutic agents; tuberculosis therapy with the exception of
isoniazid (isonicotinylhydrazid,INH); anti-coagulation agents; Immunomodulators that
alter immune responses such as chronic systemic corticosteroids, interleukins, or
interferons. Note: Subjects using short term (e.g. =21 days) systemic corticosteroid
treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Treatment with any agent, except recognized ART as allowed above, with documented
activity against HIV-1 within 28 days of study Day 1
- Use of medications which are associated with Torsade de Pointes.
- Current or prior history of etravirine (ETR)
- Current use of tipranavir/ritonavir or fosamprenavir/ritonavir
- Subjects receiving any prohibited medication and who are unwilling or unable to switch
to an alternate medication.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
618
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
0
0
GSK Investigational Site - Darlinghurst, Sydney
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GSK Investigational Site - Darlinghurst
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GSK Investigational Site - Sydney
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GSK Investigational Site - Prahran
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Recruitment postcode(s) [1]
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2010 - Darlinghurst, Sydney
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2010 - Darlinghurst
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2010 - Sydney
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Recruitment postcode(s) [4]
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3181 - Prahran
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Recruitment outside Australia
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Alabama
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Colorado
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District of Columbia
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Florida
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Illinois
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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France
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Montpellier Cedex 5
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France
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Paris Cedex 10
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France
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Paris Cedex 12
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France
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Paris Cedex 13
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France
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Paris
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France
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Saint Denis Cedex 01
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France
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Toulouse cedex 9
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France
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Tourcoing cedex
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Berlin
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Germany
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Hamburg
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Korea, Republic of
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Busan
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Daegu
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Daejeon
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Seoul
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Mexico
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Jalisco
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Krasnodar
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Lipetsk
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Russian Federation
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Moscow
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Russian Federation
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Orel
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Toliyatti
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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KwaZulu- Natal
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Mpumalanga
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South Africa
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Durban
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South Africa
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Observatory, Cape Town
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South Africa
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Pretoria
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Elche (Alicante)
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Vigo
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Sweden
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Göteborg
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Sweden
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
ViiV Healthcare
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Janssen Pharmaceuticals
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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GlaxoSmithKline
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Address [2]
0
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to
establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current
viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs)
plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM)
long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3,
multi-phase, randomized, open label, active-controlled, multicenter, parallel-group,
non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably
suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate
the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg
regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen
containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1)
into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral
therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB
LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were
randomized to continue their current ART regimen will be given an option to switch to CAB LA
+ RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks
oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at
Week 56.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02951052
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Trial related presentations / publications
Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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ViiV Healthcare
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02951052
Download to PDF