ANRS 0029s SimpPrEP:  A randomized controlled trial to evaluate the efficacy, acceptability and safety of event-driven pre-exposure prophylaxis for HIV using TAF/FTC in men who have sex with men in Thailand and France.

Countries: Thailand and France

Objectives:

Primary Objective

To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F/TAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.

Secondary Objectives

• To assess the efficacy of the internal active control, event-driven F/TDF, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.
• To compare the acceptability of the event-driven F/TAF strategy with the event-driven F/TDF strategy.
• To assess the safety of event-driven F/TAF relative to event-driven F/TDF, in particular renal safety.
• To evaluate the efficacy of event-driven F/TAF relative to event-driven F/TDF in averting HIV infections compared to the background HIV incidence rate

Methods:

Phase III, international, multicenter, open-label, parallel-group, randomized, controlled trial in MSM. 

A total of 262 participants per arm–524 overall–will be enrolled in Thailand and France over a two-year period and followed from one to three years after randomization depending on the date of enrollment. Participants will be randomly assigned to receive event-driven PrEP with either FTC 200 mg + TDF 300 mg or FTC 200 mg + TAF 25 mg.

Sponsor: Inserm-ANRS | Maladies Infectieuses Emergentes 

For more information, visit: www.simpprep.org