Phase 3 open-label switch study with GS-9883/F/TAF in HIV-1 subjects
Research type
Research Study
Full title
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
IRAS ID
195795
Contact name
Frank Post
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2015-004011-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 3 days
Research summary
The treatment of HIV-1 infection consists of combination antiretroviral therapy (ART) that controls HIV replication, reverses damage to the immune system and prolongs survival. Long term adherence to treatment is essential,and this is made easier by the use of drugs/regimens that have few side effects and can be given as single tablets.
This study will evaluate safety and efficacy of a novel integrase inhibitor(GS-9883) given together with emtricitabine and tenofovir alafenamide (a new formulation of an existing HIV drug) in a single tablet in patients who are currently taking HIV treatment consisting of ritonavir-boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) and who have fully suppressed HIV infection (HIVRNA < 50 copies/mL).
Approximately 520 participants will take part at approximately 95 sites globally. Participation will last approximately one year and involve 8 clinic visits. Participants will be randomised 1:1 to receive once daily GS9883/F/TAF or to remain on their current antiretroviral medications. After 48 weeks, participants will complete a follow up visit and return to their standard care.
Participants will be selected by chance to receive 1 of the following:
Treatment Group 1: Approximately 260 participants will switch to a once-daily fixed dose tablet of GS-9883/F/TAF. GS-9883/F/TAF will be supplied by Gilead
Treatment Group 2: Approximately 260 participants will remain on current antiretroviral medications which include ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC. Subjects to source their current antiretroviral medications.The safety and how well these drugs are tolerated, will be determined by using physical exams, laboratory tests, and any symptoms or problems the participants might experience during the study.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/0026
Date of REC Opinion
12 Feb 2016
REC opinion
Further Information Favourable Opinion