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Clinical Trial Summary

Objective

1. To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW

2. To evaluate ARV adherence among TGW


Clinical Trial Description

GAHT will be initiated on week 0. ARVs, either PrEP or ART, will be initiated on week 3. GAHT will then be withheld on week 5, and restart at week 8.

GAHT: Oral estradiol valerate 2 mg once daily and cyproterone acetate 25 mg once daily, which are the treatment of choice for GAHT in the TRC-ARC's Tangerine Community Health Center, will be provided to all participants.

PrEP and ART regimen: Generic fixed-dose combination of TDF 300 mg and FTC 200 mg will be used for PrEP and a generic fixed-dose combination of TDF 300 mg, FTC 200 mg and efavirenz 600 mg will be used for ART as recommended in the 2017 Thailand National Guidelines on HIV/AIDS Treatment and Prevention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03620734
Study type Observational
Source Thai Red Cross AIDS Research Centre
Contact
Status Completed
Phase
Start date November 30, 2017
Completion date October 1, 2019