Trials / Completed
CompletedNCT03620734
Study to Determine Interaction Between the Use of Feminizing Hormone Therapy and Antiretroviral Agents Concomitantly Among Transgender Women
The Thai Red Cross AIDS Research Centre
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- Thai Red Cross AIDS Research Centre · Academic / Other
- Sex
- Male
- Age
- 18 Years – 40 Years
- Healthy volunteers
- —
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
Detailed 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.
Conditions
Timeline
- Start date
- 2017-11-30
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2018-08-08
- Last updated
- 2019-10-09
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT03620734. Inclusion in this directory is not an endorsement.