Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatments abc/dtg/3tc, b/f/taf, abc/dtg/3tc placebo, b/f/taf placebo
Phase phase 3
Sponsor Gilead Sciences
Start date November 2015
End date April 2017
Trial size 563 participants
Trial identifier NCT02603120, 2015-004025-14, GS-US-380-1844

Summary

This study will evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected adults.

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 + ABC/DTG/3TC placebo for at least 48 weeks
b/f/taf GS-9883/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
abc/dtg/3tc placebo
Tablets administered orally once daily without regard to food
(Active Comparator)
ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
abc/dtg/3tc Triumeq®
600/50/300 mg FDC 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 96 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 with virologic failure (HIV-1 RNA ≥ 50 copies/mL) as defined by the modified US FDA-defined snapshot algorithm
time frame: Week 48

Secondary Outcomes

Measure
Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA-defined snapshot algorithm
time frame: Week 48
Change from baseline in CD4+ cell count at Week 48
time frame: Baseline and Week 48
Percentage change from baseline in hip and spine bone mineral density (BMD) at Week 48
time frame: Baseline and Week 48

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) - Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit - HIV RNA < 50 copies/mL at the screening visit - Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). - Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC Key Exclusion Criteria: - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - Active tuberculosis infection - Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) - Females who are pregnant - Females who are breastfeeding - Acute hepatitis in the 30 days prior to study entry - Chronic Hepatitis B Virus (HBV) infection 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 Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.