- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03620734
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
Objective
- To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW
- To evaluate ARV adherence among TGW
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bangkok
-
Ratchadamri, Bangkok, Thailand, 10330
- The Thai Red Cross AIDS Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Thai nationality
- Age 18-40 years old
- Male-to-female transgender individual
- PrEP/ART naïve
- Body mass index 18.5-25 kg/m2
- Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft- Gault equation
- Alanine aminotransferase (ALT) ≤2.5 x ULN
- Have signed the informed consent form
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
- CD4 < 350 cells/mm3
- History of psychiatric disorder that may be worsening by taking EFV
- Previous use of injectable GAHT in the past 6 months
Current use of any of the following medication:
- Anticonvulsant: Phenytoin, carbamazepine or phenobarbitol
- Ergot-containing agents: dihydroergotamine, ergotamine or other ergot derivatives
- Sedatives: Midazolam or triazolam
- Herbs: Gingko biloba, St John's wort or milk thistle
- Anti-infective agents: Erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin or rifabutin
- Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Measured at week 5 and week 8 of the study period
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- iFACT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PrEP and ART
-
University of WashingtonNational Institute of Mental Health (NIMH); Harvard UniversityCompleted
-
University of WashingtonNational Institute of Mental Health (NIMH)Enrolling by invitationPrEP | HIV | PMTCT | Linkage to Care | ART AdherenceUganda
-
University of WashingtonNational Institute of Mental Health (NIMH); University of North Carolina, Chapel... and other collaboratorsCompletedPrEP | HIV | PMTCT | Linkage to Care | ART AdherenceUganda
-
The University of Texas Health Science Center,...Merck Sharp & Dohme LLCCompletedPrEP Uptake Perspectives | PrEP Uptake Experiences | PrEP Adherence Perspectives | PrEP Adherence ExperiencesUnited States
-
Assiut UniversityWithdrawn
-
Karadeniz Technical UniversityCompleted
-
University of ChicagoNorthwestern University; Ann & Robert H Lurie Children's Hospital of Chicago; Howard Brown Health Center and other collaboratorsRecruiting
-
Instituto Valenciano de Infertilidade de LisboaCompleted
-
Wolfson Medical CenterUnknown
-
NYU Langone HealthCompleted