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
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 Type
OBSERVATIONAL
Enrollment
40
The Thai Red Cross AIDS Research Centre
Ratchadamri, Bangkok, Thailand
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) maximum plasma concentration (Cmax) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) trough plasma concentration (C24) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
Geometric mean (%CV) half-life (t1/2) of estradiol
Time frame: Measured at week 3 and week 5 of the study period
Geometric mean (%CV) half-life (t1/2) of tenofovir
Time frame: Measured at week 5 and week 8 of the study period
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