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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/NCT01231516
Registration number
NCT01231516
Ethics application status
Date submitted
21/10/2010
Date registered
1/11/2010
Date last updated
15/03/2022
Titles & IDs
Public title
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
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Scientific title
A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults
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Secondary ID [1]
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2009-018001-51
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Secondary ID [2]
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111762
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Universal Trial Number (UTN)
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Trial acronym
SAILING
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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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0
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Studies of infection and infectious agents
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Infection
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0
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0
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Other infectious diseases
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Infection
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0
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0
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Sexually transmitted infections
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Infection
0
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0
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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
Treatment: Drugs - Raltegravir
Treatment: Drugs - GSK1349572 Placebo
Treatment: Drugs - Raltegravir Placebo
Experimental: GSK1349572 + Raltegravir Placebo - Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.
Active Comparator: Raltegravir + GSK1349572 Placebo - Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.
Treatment: Drugs: GSK1349572
50mg once daily
Treatment: Drugs: Raltegravir
400mg twice daily
Treatment: Drugs: GSK1349572 Placebo
Inactive placebo tablet once daily
Treatment: Drugs: Raltegravir Placebo
Inactive placebo tablet twice daily
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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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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
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Assessment method [1]
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The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol 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 was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study.
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Timepoint [1]
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At Week 48
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Secondary outcome [1]
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Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Integrase Inhibitor (INI) Resistance at Time of Protocol Defined Virology Failure (PDVF)
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Assessment method [1]
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For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 logarithm to base 10 (log10) copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/ mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.
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Timepoint [1]
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Baseline (Day 1) until PDVF (Up to Week 48)
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Secondary outcome [2]
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Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
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Assessment method [2]
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The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol 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 was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis.
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Timepoint [2]
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At Week 24
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Secondary outcome [3]
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Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48
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Assessment method [3]
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The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol 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 was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment.
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Timepoint [3]
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At Week 24 and Week 48
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Secondary outcome [4]
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Absolute Values of Cluster of Differentiation 4+ (CD4+) Cell Counts at Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
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Assessment method [4]
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Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Median and interquartile range are presented. Baseline was the latest pre-dose assessment value (Day 1).
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Timepoint [4]
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Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
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Secondary outcome [5]
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Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144
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Assessment method [5]
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Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline was the latest pre-dose assessment value (Day 1). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Median and interquartile range is presented.
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Timepoint [5]
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Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
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Secondary outcome [6]
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Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions
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Assessment method [6]
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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 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 clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C:Clinical CON listed in acquired immunodeficiency syndrome (AIDS) surveillance case definition. Indicators of CDP defined as:CDC CAT A at Baseline (BS) to CDC CAT C event (EV); CDC CAT B at BS to CDC CAT C EV; CDC CAT C at BS to new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.
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Timepoint [6]
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Up to Week 480
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Secondary outcome [7]
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Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
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Assessment method [7]
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All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, 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, 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. Higher the grade, more severe the symptoms.
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Timepoint [7]
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From Baseline (Day 1) until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study
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Secondary outcome [8]
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Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
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Assessment method [8]
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Blood samples were collected for the analysis of clinical chemistry and hematology parameters: Alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hypoonatremia, LDL cholesterol, lipase, total bilirubin, triglycerides, hemoglibin, neutrophils, platelets, white blood cells. Any abnormality in clinical chemistry and hematology parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).Higher the grade, more severe the symptoms.
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Timepoint [8]
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From Week 48 to Week 480
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Secondary outcome [9]
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DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg)
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Assessment method [9]
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Cmax, Cmin and C0_avg were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. Cmax, Cmin and C0_avg were estimated and reported here.
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Timepoint [9]
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Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48
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Secondary outcome [10]
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DTG PK Parameter Including Pre-dose Concentration (C0)
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Assessment method [10]
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C0 was assessed by population PK modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 was estimated and reported here.
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Timepoint [10]
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Pre-dose at Weeks 4, 24 and 48
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Secondary outcome [11]
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DTG PK Parameters Including Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau Over a Dosing Interval at Steady State (AUC[0-tau])
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Assessment method [11]
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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. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48.
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Timepoint [11]
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Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48
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Secondary outcome [12]
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Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score
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Assessment method [12]
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The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-3L utility score ranges from -0.594 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.
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Timepoint [12]
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Baseline (Day 1) and at Weeks 24 and 48
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Secondary outcome [13]
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Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores
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Assessment method [13]
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The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. EQ-5D-3L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Participants were asked to rate their current health status using the visual analogue scale 'Thermometer'. Score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better heath. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.
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Timepoint [13]
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Baseline (Day 1) and at Weeks 24 and 48
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Eligibility
Key inclusion criteria
- Antiretroviral therapy (ART)-experienced, Human Immunodeficiency Virus (HIV) -1
infected adults at least 18 years of age.
- Women capable of becoming pregnant must use appropriate contraception during the study
(as defined by the protocol).
- HIV-1 infection as documented by HIV-1 RNA >400 copies/mL (c/mL) at Screening and with
at least one consecutive HIV-1 RNA >400 c/mL within the four months prior to Screening
(unless the Screening HIV-1 RNA is > 1000 c/mL where no additional plasma HIV-1 RNA
assessment is needed).
- Have documented resistance (via Screening resistance test) to two or more different
classes of antiretroviral agents. For subjects off ART for at least one month, if
Screening resistance results provide a fully active agent and do not show two class
resistance then historical resistance results from the subject's most recent
resistance testing may be used, following consultation with the study virologist and
/or medical monitor.
- Integrase inhibitor (INI)-naïve, defined as no prior exposure to any INI (e.g. RAL,
elvitegravir, or GSK1349572).
- Able to provide written informed consent prior to Screening.
- French subjects: In France, subjects will be eligible for inclusion in this study only
if either affiliated to or a beneficiary of a social security category.
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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
- Screening resistance test result indicates no fully active antiviral agents are
available for design of the background regimen.
- Subject-virus does not yield results using genotype/phenotype/tropism at Screening
(assay data is essential for eligibility determination).
- Women who are breastfeeding.
- Any evidence of an active AIDS-defining condition (except cutaneous Kaposi's sarcoma
not requiring systemic therapy or CD4+ <200c/mm3).
- Subjects with moderate to severe hepatic impairment as defined by Child-Pugh
classification.
- Recent history (less than or equal to 3 months) of upper or lower gastrointestinal
bleed, with the exception of anal or rectal bleeding.
- Anticipated need for hepatitis C therapy during the study.
- History or presence of allergy or intolerance to the study drugs or their components
or drugs of their class.
- History of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
squamous cell carcinoma; other localized malignancies require agreement between the
investigator and study medical monitor for inclusion of the subject.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to Screening.
- Treatment with any of the following agents within 28 days of Screening: radiation
therapy, cytotoxic chemotherapeutic agents, any immunomodulator.
- Treatment with any agent, other than licensed ART, which has documented activity
against HIV-1 in vitro within 28 days of first dose of investigational product.
- Exposure to an experimental drug and/or experimental vaccine within either 28 days, 5
half-lives of the test agent, or twice the duration of the biological effect of the
experimental test agent - whichever is longer, prior to the first dose of IP.
- French subjects recruited at sites in France will be excluded if the subject has
participated in any study using an investigational drug and/or vaccine within 60 days
or 5 half-lives, or twice the duration of the biological effect of the experimental
drug or vaccine - whichever is longer - prior to screening for the study or the
subject plans to participate simultaneously in another clinical study.
- Any acute or verified Grade 4 laboratory abnormality.
- Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).
- ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN
(with >35% direct bilirubin).
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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
26/10/2010
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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
2/02/2021
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Sample size
Target
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Accrual to date
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Final
724
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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 - 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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3004 - Melbourne
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Recruitment outside Australia
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0
United States of America
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State/province [1]
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Alabama
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0
0
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Arizona
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Arkansas
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California
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Connecticut
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District of Columbia
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Florida
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0
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Georgia
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Illinois
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Indiana
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Iowa
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0
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Massachusetts
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0
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Michigan
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Minnesota
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0
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Missouri
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0
0
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Nebraska
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0
0
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New Jersey
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0
0
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New York
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North Carolina
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Ohio
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Rhode Island
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Texas
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0
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Utah
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Virginia
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0
0
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Washington
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Argentina
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Buenos Aires
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0
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Argentina
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0
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Santa Fe
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Argentina
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0
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Ciudad Autonoma de Buenos Aires
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0
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Charleroi
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Brazil
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Minas Gerais
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Brazil
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Paraná
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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0
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Brazil
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Salvador
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0
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Brazil
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Santos
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0
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Brazil
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0
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Vitoria
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0
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Canada
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0
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British Columbia
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0
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Canada
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Ontario
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0
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Canada
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Quebec
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0
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Chile
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Región Metro De Santiago
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Chile
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Santiago
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0
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France
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State/province [47]
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0
Bordeaux
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Country [48]
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0
France
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State/province [48]
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0
Garches
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Country [49]
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0
France
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State/province [49]
0
0
Le Kremlin Bicêtre cedex
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Country [50]
0
0
France
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State/province [50]
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0
Le Kremlin-Bicêtre Cedex
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Country [51]
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0
France
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0
Marseille
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Country [52]
0
0
France
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Nice
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Country [53]
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0
France
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Orléans
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Country [54]
0
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France
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Paris Cedex 10
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Country [55]
0
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France
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State/province [55]
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0
Paris Cedex 13
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Country [56]
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France
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State/province [56]
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0
Paris Cedex 20
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Country [57]
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0
France
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State/province [57]
0
0
Paris
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Country [58]
0
0
France
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0
Tourcoing cedex
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Greece
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State/province [59]
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0
Athens
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Country [60]
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Greece
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Piraeus
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Greece
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Rio, Patras
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Hungary
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Budapest
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Country [63]
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Italy
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Emilia-Romagna
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Country [64]
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Italy
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Lombardia
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Country [65]
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Italy
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State/province [65]
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Piemonte
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Country [66]
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Italy
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State/province [66]
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Sardegna
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Country [67]
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Mexico
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State/province [67]
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Estado De México
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Mexico
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Guanajuato
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Country [69]
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Mexico
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Jalisco
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Mexico
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Mexico City
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Poland
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State/province [73]
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Chorzow
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Romania
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Bucharest
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Romania
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Constanta
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Country [76]
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Russian Federation
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State/province [76]
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Ekaterinburg
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Country [77]
0
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Russian Federation
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State/province [77]
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Kazan
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Country [78]
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Russian Federation
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State/province [78]
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Krasnodar
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Country [79]
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Russian Federation
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State/province [79]
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Moscow
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Country [80]
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Russian Federation
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State/province [80]
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0
N.Novgorod
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Country [81]
0
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Russian Federation
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State/province [81]
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Perm
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Country [82]
0
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Russian Federation
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State/province [82]
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Ryazan
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Country [83]
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Russian Federation
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State/province [83]
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Saint-Petersburg
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Country [84]
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Russian Federation
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Saratov
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Country [85]
0
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Russian Federation
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State/province [85]
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Toliyatti
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Country [86]
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Russian Federation
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State/province [86]
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Volgograd
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Country [87]
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0
South Africa
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State/province [87]
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Bloemfontein
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Country [88]
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South Africa
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State/province [88]
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Dundee
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Country [89]
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South Africa
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State/province [89]
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Durban
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Country [90]
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Spain
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State/province [90]
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0
(Móstoles) Madrid
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Country [91]
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Spain
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State/province [91]
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Alicante
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Country [92]
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Spain
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State/province [92]
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Badalona
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Country [93]
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Spain
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State/province [93]
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Barcelona
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Country [94]
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0
Spain
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State/province [94]
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0
Cartagena (Murcia)
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Country [95]
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Spain
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State/province [95]
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Elche (Alicante)
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Country [96]
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Spain
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State/province [96]
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Granada
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Country [97]
0
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Spain
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State/province [97]
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Granollers (Barcelona)
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Country [98]
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Spain
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State/province [98]
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La Coruña
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Country [99]
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Spain
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State/province [99]
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Madrid
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Country [100]
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Spain
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State/province [100]
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Mataró
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Country [101]
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Spain
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State/province [101]
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Murcia
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Country [102]
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0
Spain
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State/province [102]
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0
Sabadell (Barcelona)
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Country [103]
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Spain
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State/province [103]
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San Sebastián
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Country [104]
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Spain
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State/province [104]
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Sevilla
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Country [105]
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0
Spain
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State/province [105]
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Valencia
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Country [106]
0
0
Taiwan
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State/province [106]
0
0
Kaohsiung
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Country [107]
0
0
Taiwan
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State/province [107]
0
0
Taichung
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Country [108]
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0
Taiwan
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State/province [108]
0
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Taipei
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Country [109]
0
0
United Kingdom
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State/province [109]
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London
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Country [110]
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0
United Kingdom
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State/province [110]
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0
Crumpsall, Manchester
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Country [111]
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0
United Kingdom
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State/province [111]
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0
Liverpool
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Country [112]
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0
United Kingdom
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State/province [112]
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Tooting, 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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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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0
Shionogi
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Address [1]
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0
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Country [1]
0
0
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Other collaborator category [2]
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0
Commercial sector/Industry
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Name [2]
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GlaxoSmithKline
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Address [2]
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0
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Country [2]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel
group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected
antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to
receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an
investigator selected background regimen consisting of at least one fully active agent plus
no more than one second single agent which may or may not be active. Antiviral activity,
safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01231516
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Trial related presentations / publications
Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3. Erratum In: Lancet. 2014 Jan 4;383(9911):30.
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Public notes
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Contacts
Principal investigator
Name
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0
GSK Clinical Trials
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Address
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ViiV Healthcare
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0
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01231516
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