Study of a Single Double Dose of FTAF Tablets to Understand Drug Levels in Healthy Adults for HIV Prevention

What this Trial Is About

Researchers are studying how a single dose of two FTAF tablets behaves in the body over a 14-day period to better understand HIV prevention using oral pre-exposure prophylaxis PrEP. This study focuses on measuring the levels of the drugs tenofovir alafenamide TAF, tenofovir TFV, and emtricitabine FTC, as well as their active forms inside cells, to explore if less frequent dosing could be effective for preventing HIV. Participants will receive a one-time double dose consisting of two tablets of Descovy, which contains tenofovir alafenamide 25 mg and emtricitabine 200 mg each. After taking the dose, they will be followed closely with intensive blood sampling initially, which becomes less frequent over the next 14 days to analyze the drugs behavior in the body. This study is a phase 1 trial focused on healthy volunteers. During the 14-day follow-up, participants will undergo pharmacokinetic assessments to measure intracellular tenofovir-diphosphate concentrations at various time points. The study includes medical history reviews, physical exams, vital signs, laboratory tests including HIV and hepatitis B screening, and monitoring for safety. The goal is to collect detailed data on how the drugs are processed and maintained in the body to inform future dosing strategies for HIV prevention.

Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers