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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/NCT01227824
Registration number
NCT01227824
Ethics application status
Date submitted
14/10/2010
Date registered
25/10/2010
Date last updated
9/10/2018
Titles & IDs
Public title
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
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Scientific title
A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
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Secondary ID [1]
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113086
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Universal Trial Number (UTN)
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Trial acronym
SPRING-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infection, Human Immunodeficiency Virus I
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Condition category
Condition code
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 - GSK1349572 (dolutegravir)
Treatment: Drugs - raltegravir
Other interventions - GSK1349572 Placebo
Other interventions - ABC/3TC
Other interventions - TDF/FTC
Other interventions - raltegravir Placebo
Experimental: GSK1349572 (N=~394) - GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily
Active Comparator: raltegravir (N=~394) - raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily
Treatment: Drugs: GSK1349572 (dolutegravir)
GSK1349572 50 mg taken once daily with or without food
Treatment: Drugs: raltegravir
raltegravir 400mg taken twice daily
Other interventions: GSK1349572 Placebo
GSK1349572 placebo taken once daily
Other interventions: ABC/3TC
Abacavir/Lamivudine background therapy once daily
Other interventions: TDF/FTC
Tenofovir/emtricitabine background therapy once daily
Other interventions: raltegravir Placebo
raltegravir placebo taken twice daily
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48
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Assessment method [1]
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Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication.
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Timepoint [1]
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Baseline up to Week 48
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Secondary outcome [1]
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Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.
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Assessment method [1]
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Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.
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Timepoint [1]
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Week 48 and Week 96
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Secondary outcome [2]
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Number of Participants With Plasma HIV-1 RNA <50 c/mL
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Assessment method [2]
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The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.
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Timepoint [2]
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Week 96
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Secondary outcome [3]
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Number of Participants With Plasma HIV-1 RNA <400 c/mL
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Assessment method [3]
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The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.
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Timepoint [3]
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Week 48 and Week 96
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Secondary outcome [4]
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Change From Baseline in Plasma HIV-1 RNA Over Time
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Assessment method [4]
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Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
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Timepoint [4]
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Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
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Secondary outcome [5]
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Absolute Values in Plasma HIV-1 RNA Over Time
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Assessment method [5]
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Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
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Timepoint [5]
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Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
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Secondary outcome [6]
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Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time
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Assessment method [6]
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CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
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Timepoint [6]
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Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
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Secondary outcome [7]
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Absolute Values in CD4+ Cell Counts Over Time
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Assessment method [7]
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CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
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Timepoint [7]
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Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
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Secondary outcome [8]
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Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences
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Assessment method [8]
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Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death.
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Timepoint [8]
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From Baseline until Week 96
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Secondary outcome [9]
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Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)
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Assessment method [9]
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All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. Safety Population: all participants who received at least one dose of investigational product
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Timepoint [9]
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From Baseline until Week 96
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Secondary outcome [10]
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Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG
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Assessment method [10]
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AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.
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Timepoint [10]
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Week 4, Week 24, and Week 48
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Secondary outcome [11]
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Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG
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Assessment method [11]
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The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.
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Timepoint [11]
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Week 4, Week 24, and Week 48
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Eligibility
Key inclusion criteria
- Screening plasma HIV-1 RNA =1000 c/mL
- Antiretroviral-naïve (= 10 days of prior therapy with any antiretroviral agent
following a diagnosis of HIV-1 infection)
- Ability to understand and sign a written informed consent form
- Willingness to use approved methods of contraception to avoid pregnancy (women of
child bearing potential only)
- Age equal to or greater than 18 years
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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
- Women who are pregnant or breastfeeding;
- Active Center for Disease and Prevention Control (CDC) Category C disease
- Moderate to severe hepatic impairment
- Anticipated need for HCV therapy during the study
- Allergy or intolerance to the study drugs or their components or drugs of their class
- Malignancy within the past 5 years
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any
immunomodulator within 28 days of Screening
- Exposure to an agent with documented activity against HIV-1 in vitro or an
experimental vaccine or drug within 28 days of first dose of study medication
- Primary viral resistance in the Screening result
- Verified Grade 4 laboratory abnormality
- ALT >5 xULN
- ALT = 3xULN and bilirubin = 1.5xULN (with >35% direct bilirubin);
- Estimated creatinine clearance <50 mL/min
- Recent history (=3 months) of upper or lower gastrointestinal bleed
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
Completed
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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
19/10/2010
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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
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Actual
27/12/2016
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Sample size
Target
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Accrual to date
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Final
828
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Darlinghurst
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Recruitment hospital [2]
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GSK Investigational Site - Surry Hills
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Recruitment hospital [3]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2010 - Surry Hills
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
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Arizona
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Missouri
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New Jersey
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North Carolina
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South Carolina
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Garches
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France
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Le Kremlin Bicêtre cedex
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France
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Levallois Perret
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France
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Lyon Cedex 03
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France
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Marseille
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France
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Nantes
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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 Cedex 4
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France
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Paris
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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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Nordrhein-Westfalen
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Veneto
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Russian Federation
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Krasnodar
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Russian Federation
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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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N.Novgorod
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Russian Federation
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Orel
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Russian Federation
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Perm
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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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Volgograd
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Spain
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(Móstoles) Madrid
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Spain
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Alcala de Henares
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Alicante
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Spain
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Almería
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Spain
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Badalona
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Spain
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Barcelona
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Cartagena (Murcia)
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Spain
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Córdoba
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Granada
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Spain
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La Coruña
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Spain
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La Laguna (Santa Cruz De Tenerife)
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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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Mataró
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Spain
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Murcia
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Spain
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San Sebastián
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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 ( Pontevedra)
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United Kingdom
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Warwickshire
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United Kingdom
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Brighton
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United Kingdom
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Crumpsall, Manchester
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United Kingdom
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London
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Shionogi
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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]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50
mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested
at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI
therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult
subjects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01227824
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Trial related presentations / publications
Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.
Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.
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Contacts
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GSK Clinical Trials
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ViiV Healthcare
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01227824
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