Overview

This trial is active, not recruiting.

Condition infection, human immunodeficiency virus i
Treatments dolutegravir, atripla, abacavir/lamivudine, abacavir/lamivudine placebo, dolutegravir placebo, atripla placebo
Phase phase 3
Sponsor ViiV Healthcare
Collaborator Shionogi
Start date February 2011
End date September 2012
Trial size 844 participants
Trial identifier NCT01263015, 114467

Summary

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Dolutegravir 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily
dolutegravir
Dolutegravir (also known as GSK1349572) 50 mg taken once daily
abacavir/lamivudine
taken once daily; also known as EPZICOM
atripla placebo
matching placebo taken once daily on an empty stomach
(Active Comparator)
Atripla once daily + Dolutegravir placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily
atripla
Atripla once daily on an empty stomach
abacavir/lamivudine placebo
matching placebo taken once daily
dolutegravir placebo
matching placebo taken once daily

Primary Outcomes

Measure
Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
time frame: Week 48

Secondary Outcomes

Measure
Time to Viral Suppression (<50 c/mL)
time frame: From Baseline until data cut off for Week 48 analysis (average of 357.0 days for DTG; average of 332.2 study days for EFV/TDF/FTC)
Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24
time frame: From Baseline until data cut off for the Week 48 analysis (average of 357.0 study days for DTG; average of 332.2 study days for EFV/TDF/FTC)
Change From Baseline in Plasma HIV-1 RNA at Weeks 4, 8, 12, 24, 32, and 48
time frame: Baseline and Weeks 4, 8, 12, 24, 32, and 48
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 48
time frame: Baseline and Week 48
Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences
time frame: From Baseline until Week 48
Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities
time frame: From Baseline until data cut off for the Week 48 analysis (average of 357.0 study days for DTG; average of 332.2 study days for EFV/TDF/FTC)
Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF)
time frame: Baseline to the time of virological failure (up to Week 48)
Change From Baseline in the Symptom Bother Score (SBS) at Week 4
time frame: Baseline and Week 4

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 - A negative HLAB*5701 allele assessment Exclusion Criteria: - Women who are pregnant or breastfeeding; - Active Center for Disease and Prevention Control (CDC) Category C disease - Hepatic impairment - HBV co-infection - 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 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
Description ING114467 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: GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately 394 subjects) OR Atripla once daily (approximately 394 subjects) 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 plus abacavir/lamivudine fixed-dose combination through the study until it is locally available-as long as they continue to derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated. 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 May 2014.
Information provided to ClinicalTrials.gov by ViiV Healthcare.