RTV
Drug100 mg capsule coadministered orally with ATV or DRV once daily with food
NCT Number: NCT02603107
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Darlinghurst, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
100 mg capsule coadministered orally with ATV or DRV once daily with food
300 mg capsule administered orally once daily with food
800 mg tablet administered orally once daily with food
150 mg tablet coadministered orally with ATV or DRV once daily with food
Other names: Tybost®, GS-9350
300/150 mg FDC tablet administered orally once daily with food
Other names: Evotaz®
800/150 mg FDC tablet administered orally once daily with food
Other names: Prezcobix®
200/300 mg FDC tablet administered orally once daily without regard to food
Other names: Truvada®
600/300 mg tablet administered orally once daily with or without regard to food
50/200/25 mg FDC tablet administered orally once daily without regard to food
Other names: Biktarvy®
Time frame: Week 48
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Baseline to Week 48
Gilead Sciences
Industry
A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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