Switch from (ABC/3TC) plus a Third Antiretroviral to E/C/F/TAF/FDC
Research type
Research Study
Full title
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects
IRAS ID
189422
Contact name
Dr Laura Waters
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2015-002711-15
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Combination HIV treatment has transformed the outlook for HIV patients. Starting treatment earlier will improve life expectancy and quality of life, although patients will potentially take treatment for decades. Longer treatment duration and an ageing HIV population require drug regimens that encourage patient adherence, prevention of drug resistance and minimal long-term toxicities. Most patients are treated with a combination of drugs, 2 nucleoside analogues plus one drug from another class. The preferred nucleoside analogue, Tenofovir disoproxil fumarate (TDF), for first-line HIV treatment, is associated with kidney toxicity and reduced bone mineral density (BMD - bone thinning). Tenofovir alafenamide fumarate (TAF) is an investigational version of tenofovir with similar effectiveness against HIV but less impact on kidney and bone.
The purpose of the study sponsored by Gilead Sciences, Inc is to evaluate the safety & effectiveness of switching from regimens consisting of Abacavir/Lamivudine (ABC/3TC) plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in adult HIV-1 infected patients who are virologically suppressed.
300 participants will take part in this study at 55 sites in Europe and North America. Participation will last about 48 weeks, not including an initial screening period up to 42 days. Participants will be required to visit the clinic at least 8 times including a follow-up visit.
Participants will be selected by chance to receive one of the following:
•Treatment Group 1: Immediate switch from ABC/3TC plus a third antiretroviral agent to E/C/F/TAF FDC(n = approximately 200)
•Treatment Group 2: Continue on the current regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to fixed-dose regimen consisting of E/C/F/TAF FDC(n = approximately 100)REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0169
Date of REC Opinion
18 Nov 2015
REC opinion
Further Information Favourable Opinion