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OpenTrials
Completed

NCT Number: NCT03620734

Study to Determine Interaction Between the Use of Feminizing Hormone Therapy and Antiretroviral Agents Concomitantly Among Transgender Women

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

Completed

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Key information

Conditions

PrEP and ART

Age range

18 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Ratchadamri, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. Geometric mean (%CV) maximum plasma concentration (Cmax) of estradiol

    Time frame: Measured at week 3 and week 5 of the study period

  4. Geometric mean (%CV) maximum plasma concentration (Cmax) of tenofovir

    Time frame: Measured at week 5 and week 8 of the study period

  5. Geometric mean (%CV) trough plasma concentration (C24) of estradiol

    Time frame: Measured at week 3 and week 5 of the study period

  6. Geometric mean (%CV) trough plasma concentration (C24) of tenofovir

    Time frame: Measured at week 5 and week 8 of the study period

  7. Geometric mean (%CV) half-life (t1/2) of estradiol

    Time frame: Measured at week 3 and week 5 of the study period

  8. Geometric mean (%CV) half-life (t1/2) of tenofovir

    Time frame: Measured at week 5 and week 8 of the study period

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Registry information

Official study title

The Thai Red Cross AIDS Research Centre

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.