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Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women

NCT04590417 NA ACTIVE_NOT_RECRUITING

Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among transgender women (TGW). New strategies for PrEP among TGW who use FHT are urgently needed. Because tenofovir alafenamide (TAF) can achieve higher intracellular TFV-DP levels with lower tenofovir plasma concentrations, it is promising that both plasma TFV and intracellular TFV-DP levels might not be significantly affected by FHT. The current study aims to determine the pharmacokinetics DDI between FHT and F/TAF-based PrEP among TGW.

Details

Lead sponsorThai Red Cross AIDS Research Centre
PhaseNA
StatusACTIVE_NOT_RECRUITING
Enrolment20
Start dateMon Jan 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionWed Oct 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Thailand