Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objective
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAHT and PrEP | HIV-negative TGW will have HIV testing using the 4th generation immunoassays/nucleic acid testing (NAT) in acute HIV testing algorithm currently used at the Thai Red Cross Anonymous Clinic at week 5, 8, and 15. Creatinine clearance will be performed at week 15. | ||
| GAHT and ART | HIV-positive TGW on ART will have their plasma HIV RNA measured at the same day ART is initiated and at week 15 (12 weeks after ART provision). CD4 count will be measure at week 15. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean (%CV) area under the plasma concentration time curve from 0 to 24 hours (AUC0-24) of estradiol | 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 | Measured at week 5 and week 8 of the study period | |
| Geometric mean (%CV) maximum plasma concentration (Cmax) of estradiol | Measured at week 3 and week 5 of the study period | |
| Geometric mean (%CV) maximum plasma concentration (Cmax) of tenofovir | Measured at week 5 and week 8 of the study period | |
| Geometric mean (%CV) trough plasma concentration (C24) of estradiol | Measured at week 3 and week 5 of the study period | |
| Geometric mean (%CV) trough plasma concentration (C24) of tenofovir | Measured at week 5 and week 8 of the study period | |
| Geometric mean (%CV) half-life (t1/2) of estradiol | Measured at week 3 and week 5 of the study period | |
| Geometric mean (%CV) half-life (t1/2) of tenofovir | Measured at week 5 and week 8 of the study period |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Known history of allergy to hormonal or ARV component to be used in the study
Male-to-female transgender who underwent orchiectomy
Any of the following in HIV-infected participants
Previous use of injectable GAHT in the past 6 months
Current use of any of the following medication:
Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Not provided
Not provided
Not provided
transgender women (TGW)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nittaya Phanuphak, MD, PhD | Thai Red Cross AIDS Research Centre (TRCARC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Thai Red Cross AIDS Research Centre | Ratchadamri | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31298497 | Derived | Hiransuthikul A, Janamnuaysook R, Himmad K, Kerr SJ, Thammajaruk N, Pankam T, Phanjaroen K, Mills S, Vannakit R, Phanuphak P, Phanuphak N; iFACT Study Team. Drug-drug interactions between feminizing hormone therapy and pre-exposure prophylaxis among transgender women: the iFACT study. J Int AIDS Soc. 2019 Jul;22(7):e25338. doi: 10.1002/jia2.25338. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided