CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 567 enrolled
Drug / intervention
ABC/DTG/3TC +3 moredrug
Likely dose
ABC/DTG/3TC 300 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/NCT02603120
NCT02603120Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Nov 11, 2015·Updated Nov 12, 2020

In Brief

A Phase 3 clinical trial evaluating ABC/DTG/3TC, B/F/TAF, and 2 other interventions for HIV-1 Infection. Completed, enrolled 567 participants across 94 sites in 10 countries.

Detailed Summary

The primary objective of this study is to 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 Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 11, 2015
Enrollment StartNov 11, 2015
Primary CompletionMay 9, 2017
Study CompletionOct 23, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.6 years ago

Interventions

ABC/DTG/3TCdrug

600/50/300 mg FDC tablets administered orally once daily without regard to food

B/F/TAFdrug

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

ABC/DTG/3TC Placebodrug

Tablets administered orally once daily without regard to food

B/F/TAF Placebodrug

Tablets administered orally once daily without regard to food