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Clinical trial

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

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Last updated:11th Nov 2015
Identifier: NCT02603120

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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date: November 11, 2015
Actual Primary Completion Date: May 9, 2017
Estimated Study Completion Date: July 2019

Arm:
- Experimental:
Blinded Phase: B/F/TAF
- Active Comparator: Blinded Phase: ABC/DTG/3TC
- Experimental: Open-Label Phase


Related journal:
- Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial.

Category Value
Date last updated at source 2017-11-21
Study type(s) Interventional
Expected enrolment 567
Study start date 2015-11-11
Estimated primary completion date 2017-05-09

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