Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatments dtg, f/taf, b/f/taf, dtg placebo, f/taf placebo, b/f/taf placebo
Phase phase 3
Sponsor Gilead Sciences
Start date November 2015
End date May 2017
Trial size 645 participants
Trial identifier NCT02607956, 2015-003988-10, GS-US-380-1490

Summary

This study will evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults at Week 48.

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, investigator)
Primary purpose treatment
Arm
(Experimental)
B/F/TAF + DTG placebo + F/TAF placebo for at least 96 weeks
b/f/taf GS-9883/F/TAF
50/200/25 mg FDC tablets administered orally, once daily, without regard to food
dtg placebo
Tablets administered orally, once daily, without regard to food
f/taf placebo
Tablets administered orally, once daily, without regard to food
(Experimental)
DTG+F/TAF + B/F/TAF placebo for at least 96 weeks
dtg
50 mg tablets administered orally, once daily, without regard to food
f/taf
200/25 mg tablets administered orally, once daily, without regard to food
b/f/taf placebo
Tablets administered orally, once daily, without regard to food
(Experimental)
At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 144 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.
b/f/taf GS-9883/F/TAF
50/200/25 mg FDC tablets administered orally, once daily, without regard to food

Primary Outcomes

Measure
Proportion of Participants who Achieve HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
time frame: Week 48

Secondary Outcomes

Measure
Proportion of Participants who Achieve HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
time frame: Week 96
Proportion of Participants who Achieve HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
time frame: Week 144
Proportion of Participants who Achieve HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
time frame: Week 48
Proportion of Participants who Achieve HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
time frame: Week 96
Proportion of Participants who Achieve HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
time frame: Week 144
Change from Baseline in log10 HIV-1 RNA at Week 48
time frame: Baseline; Week 48
Change from Baseline in log10 HIV-1 RNA at Week 96
time frame: Baseline; Week 96
Change from Baseline in log10 HIV-1 RNA at Week 144
time frame: Baseline; Week 144
Change from Baseline in CD4+ Cell Count at Week 48
time frame: Baseline; Week 48
Change from Baseline in CD4+ Cell Count at Week 96
time frame: Baseline; Week 96
Change from Baseline in CD4+ Cell Count at Week 144
time frame: Baseline; Week 144

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for PrEP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis), up to one month prior to screening - Plasma HIV 1 RNA levels ≥ 500 copies/mL at screening - Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL/min (≥ 0.50 mL/sec) according to the Cockcroft Gault formula Key Exclusion Criteria: - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.