Overview

This trial is active, not recruiting.

Condition infection, human immunodeficiency virus i
Treatments gsk1349572 (dolutegravir), raltegravir, gsk1349572 placebo, abc/3tc, tdf/ftc, raltegravir placebo
Phase phase 3
Sponsor ViiV Healthcare
Collaborator Shionogi
Start date October 2010
End date March 2012
Trial size 827 participants
Trial identifier NCT01227824, 113086

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily
gsk1349572 (dolutegravir)
GSK1349572 50 mg taken once daily with or without food
gsk1349572 placebo
GSK1349572 placebo taken once daily
abc/3tc
Abacavir/Lamivudine background therapy once daily
tdf/ftc
Tenofovir/emtricitabine background therapy once daily
(Active Comparator)
raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily
raltegravir
raltegravir 400mg taken twice daily
abc/3tc
Abacavir/Lamivudine background therapy once daily
tdf/ftc
Tenofovir/emtricitabine background therapy once daily
raltegravir placebo
raltegravir placebo taken twice daily

Primary Outcomes

Measure
Percentage of Participants With HIV-1RNA <50 Copies (c)/Milliliter (mL) Through Week 48.
time frame: Baseline to Week 48

Secondary Outcomes

Measure
Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.
time frame: Week 48 and Week 96
Number of Participants With Plasma HIV-1 RNA <50 c/mL
time frame: Week 96
Number of Participants With Plasma HIV-1 RNA <400 c/mL
time frame: Week 48 and Week 96
Change From Baseline in Plasma HIV-1 RNA Over Time
time frame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96
Absolute Values in Plasma HIV-1 RNA Over Time
time frame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96
Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time
time frame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96
Absolute Values in CD4+ Cell Counts Over Time
time frame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96
Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences
time frame: From Baseline until Week 96
Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)
time frame: From Baseline until Week 96
AUC(0-tau) of DTG
time frame: Week 4, Week 24, and Week 48
Cmax and Ctau of DTG
time frame: Week 4, Week 24, and Week 48

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

Official 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
Description ING113086 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms: 1. GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC) OR 2. 400 mg RAL twice daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC) Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 through the study until either it is locally available, as long as they continue to derive clinical benefit. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by ViiV Healthcare.