CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 578 enrolled
Drug / intervention
RTV +8 moredrug
Likely dose
RTV 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02603107
NCT02603107Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Nov 11, 2015·Updated Dec 29, 2020

In Brief

A Phase 3 clinical trial evaluating RTV, ATV, and 7 other interventions for HIV-1 Infection. Completed, enrolled 578 participants across 119 sites in 11 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesAustralia, Belgium, Canada, Dominican Republic, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 11, 2015
Enrollment StartNov 20, 2015
Primary CompletionMay 15, 2017
Study CompletionDec 23, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.6 years ago

Interventions

RTVdrug

100 mg capsule coadministered orally with ATV or DRV once daily with food

ATVdrug

300 mg capsule administered orally once daily with food

DRVdrug

800 mg tablet administered orally once daily with food

COBIdrug

150 mg tablet coadministered orally with ATV or DRV once daily with food

ATV/codrug

300/150 mg FDC tablet administered orally once daily with food

DRV/codrug

800/150 mg FDC tablet administered orally once daily with food

FTC/TDFdrug

200/300 mg FDC tablet administered orally once daily without regard to food

ABC/3TCdrug

600/300 mg tablet administered orally once daily with or without regard to food

B/F/TAFdrug

50/200/25 mg FDC tablet administered orally once daily without regard to food