F/TAF for pre-exposure HIV-1 prophylaxis in men & transgender women
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are at Risk of HIV-1 Infection
IRAS ID
184654
Contact name
Gary Whitlock
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-001399-31
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Oral F/TAF and F/TDF are antiretroviral therapies used to treat HIV-1 infection. Use of F/TAF for pre-exposure prophylaxis in high-risk individuals not infected with HIV-1 may effectively prevent HIV-I infection and is thought to have less effect on kidney function and bone density compared to the antiretroviral agent F/TDF (Truvada).
This study will compare the safety and effectiveness of F/TAF versus F/TDF in 5000 HIV-1 negative men and transgender women (male at birth) who are at risk of HIV-1 infection through sexual exposure with men. Participants will be assigned at random to receive either F/TAF and placebo or F/TDF and placebo in a 1:1 ratio and will not be told which treatment arm they have been assigned to.
Participants will take their assigned study treatment daily for a minimum of 96 weeks and will attend study visits at end of weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96, after which they will attend visits every 12 weeks. Once the last participant has reached week 96, all participants will attend an unblinding visit and will be informed of which treatment arm they were assigned to. All participants will be then given the option to receive open-label F/TAF and attend study visits every 12 weeks until open-label Week 48. At the open-label Week 48 visit all participants will discontinue study treatment and will return for a 30 day follow up visit.
Participants will be required to visit the clinic at least 17 times over a minimum of 144 weeks. Study procedures include physical exams, genital, rectal and pharyngeal examinations, STI tests, blood tests, urine tests and completion of study questionnaires.
Dual energy X-ray absorptiometry (DXA) scans will be performed in a subset of participants every 48 weeks, as well as the unblinding visit for participants treated with F/TDF.
Gilead Sciences, Inc. is the sponsor.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1854
Date of REC Opinion
13 Dec 2016
REC opinion
Further Information Favourable Opinion