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ACTIVE NOT RECRUITING
NCT04590417
NA

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

Sponsor: Thai Red Cross AIDS Research Centre

View on ClinicalTrials.gov

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.

Official title: Institute of HIV Research and Innovation (IHRI)

Key Details

Gender

MALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-01-24

Completion Date

2025-10-01

Last Updated

2024-11-25

Healthy Volunteers

Yes

Interventions

DRUG

Estradiol valerate 2 mg, cyproterone acetate 25 mg

The entire study period will be approximately 1 year, which will include around 2 months of document preparation, 5 months of recruitment, 3 months of follow-up, and 2 months of data analysis.

Locations (1)

Institute of HIV Research and Innovation (IHRI)

Bangkok, Pathumwan, Thailand