drugset / Trial / NCT04590417

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

NCT04590417

Active not recruiting 20 enrolled Thai Red Cross AIDS Research Centre
NaSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2022-01-24
Primary completion
2024-01-01
Completion
2025-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject estradiol valerate Unknown 2 mg Oral
Background cyproterone acetate Small molecule 25 mg Oral

Indications

No indication recorded.