1717 - Phase 3b switch study with F/TAF in HIV-1 infected subjects
Research type
Research Study
Full title
A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed on Regimens containing ABC/3TC
IRAS ID
181430
Contact name
Alan Winston
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2015-000871-28
Research summary
The treatment of HIV-1 infection uses combination antiretroviral therapy (ART). Even if ART treatment is successful against HIV-1 infection, other non AIDS associated conditions play a factor in decreased quality of life for patients and generally contribute to patient death. There is a significant need to develop safe and effective new therapies which take into consideration the aging patient population, non HIV related conditions, viral resistance and simplifying treatment regimens. Virologically suppressed HIV infected participants may benefit by switching from their current treatment regimen to improve safety or tolerability or to simplify their current regimen.
This study will test an experimental drug named emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) for the treatment of HIV-1 infection. F/TAF FDC will be compared to another drug, abacavir/lamivudine (ABC/3TC) which has been approved for use in patients with HIV-1 infection.
The purpose of this study is to test the effectiveness of switching from an ABC/3TC treatment regimen to F/TAF FDC versus continuing on ABC/3TC in virologically suppressed HIV-1 participants.
Participants will be assigned to one of two treatment groups in a 1:1 ratio:
Treatment Arm 1: F/TAF FDC + Placebo-to-match ABC/3TC FDC
Treatment Arm 2: ABC/3TC FDC + Placebo-to-match F/TAF FDC
Participants will also continue to take the medications they were previously taking with their ABC/3TC throughout the duration of the study.
Study duration will be at least 96 weeks and participants will be required to attend the clinic at least 11 times. After completing the week 96 visit, participants will remain on the study until unblinding occurs, followed by a 30 day follow up visit. Procedures involved include physical exams, vital signs, blood tests, ECGs, DEXA scans and HIV related assessments.This study is sponsored by Gilead Sciences Inc. Approximately 500 participants from 100 sites will participate. Approximately 80 participants will be recruited in the UK.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1163
Date of REC Opinion
1 Sep 2015
REC opinion
Further Information Favourable Opinion