Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women

Phase 1 Completed 16 enrolled Johns Hopkins University

Non-randomizedParallel-groupOpen-labelBasic science

Summary

This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy.

Timeline

Start: 2016-03-08
Primary completion: 2018-05-31
Completion: 2018-05-31

Publications

Shieh E, Marzinke MA, Fuchs EJ, Hamlin A, Bakshi R, Aung W, Breakey J, Poteat T, Brown T, Bumpus NN, Hendrix CW. Transgender women on oral HIV pre-exposure prophylaxis have significantly lower tenofovir and emtricitabine concentrations when also taking oestrogen when compared to cisgender men. J Int AIDS Soc. 2019 Nov;22(11):e25405. doi: 10.1002/jia2.25405.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenofovir Disoproxil Fumarate/Emtricitabine	Unknown	—	Oral

Indications

No indication recorded.