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
ID Number 17-0904Principal Investigator(s)
Michelle S Cespedes
Department(s) or Division(s)
In 2014 there were more than 2 million new HIV infections estimated world-wide even though there is widespread knowledge of how to prevent acquiring the HIV infection. In July 2012, the FDA approved to expand the use of emtricitabine/ tenofovir disopoxil fumarate (F/TDF) in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. While TDF is an effective drug used broadly (as part of multiple combination regimens) in both the treatment and prevention of HIV-1 infection, it has been associated with kidney toxicity and reduced bone mineral density.
The use of emtricitabine/ tenofovir alafenamide (F/TAF) for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in uninfected individuals at high risk may provide an effective prevention regimen with a significantly improved renal and bone safety profile relative to F/TDF. This is of particular importance for HIV-1 negative persons who are otherwise likely to be healthy, in whom the acceptability of medication related risks relative to benefit must be weighed carefully.
The primary objective of this study is to assess the rates of HIV-1 seroconversion in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily F/TAF or F/TDF with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up.
Recruiting Patients: No