Study to Determine Interaction Between the Use of Feminizing Hormone Therapy and Antiretroviral Agents Concomitantly Among Transgender Women
NCT ID: NCT03620734
Last Updated: 2019-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2017-11-30
2019-10-01
Brief Summary
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1. To determine pharmacokinetic (PK) DDI between GAHT and ARVs used as PrEP and ART among TGW
2. To evaluate ARV adherence among TGW
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age 18-40 years old
3. Male-to-female transgender individual
4. PrEP/ART naïve
5. Body mass index 18.5-25 kg/m2
6. Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft- Gault equation
7. Alanine aminotransferase (ALT) ≤2.5 x ULN
8. Have signed the informed consent form
Exclusion Criteria
2. Male-to-female transgender who underwent orchiectomy
3. Any of the following in HIV-infected participants
* CD4 \< 350 cells/mm3
* History of psychiatric disorder that may be worsening by taking EFV
4. Previous use of injectable GAHT in the past 6 months
5. 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
6. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
18 Years
40 Years
MALE
No
Sponsors
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Thai Red Cross AIDS Research Centre
OTHER
Responsible Party
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Principal Investigators
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Nittaya Phanuphak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Thai Red Cross AIDS Research Centre (TRCARC)
Locations
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The Thai Red Cross AIDS Research Centre
Ratchadamri, Bangkok, Thailand
Countries
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References
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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.
Other Identifiers
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iFACT
Identifier Type: -
Identifier Source: org_study_id
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