Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
- Conditions
- Drug Interaction
- Interventions
- Registration Number
- NCT04590417
- Lead Sponsor
- Thai Red Cross AIDS Research Centre
- Brief Summary
Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among transgender women (TGW). New strategies for PrEP among TGW who use FHT are urgently needed. Because tenofovir alafenamide (TAF) can achieve higher intracellular TFV-DP levels with lower tenofovir plasma concentrations, it is promising that both plasma TFV and intracellular TFV-DP levels might not be significantly affected by FHT. The current study aims to determine the pharmacokinetics DDI between FHT and F/TAF-based PrEP among TGW.
- Detailed Description
Two full pharmacokinetic (PK) measurements will be performed. Samples collected will include: plasma for estradiol (E2), emtricitabine (FTC), tenofovir (TFV), and tenofovir alafenamide (TAF) measurement; and peripheral blood mononuclear cells (PBMC) for emtricitabine-triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) intracellular quantification.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 20
- Thai nationality
- Age 18-40 years old
- Transgender women
- HIV-negative
- Body mass index 18.5-24.9 kg/m2
- Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft-Gault equation
- Alanine aminotransferase (ALT) ≤2.5 x ULN
- Signed the informed consent form
-
Known history of allergy to hormonal component to be used in the study
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Male-to-female transgender who underwent orchiectomy
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Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
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Use of injectable FHT in the past 3 months
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Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen (HBsAg) positive
-
Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive
-
Current use of any of the following:
- Anticonvulsants: carbamazepine, felbamate, oxcarbazepine, phenytoin, phenobarbital, primidone or topiramate
- Herbs: gingko biloba, St John's wort or milk thistle
- Anti-infective agents: azole antifungals, macrolides, griseofulvin, protease inhibitors, rifampicin or rifabutin
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Participant-reported active rectal infection requiring treatment
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History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption
-
Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 20 HIV-negative TGW Estradiol valerate 2 mg, cyproterone acetate 25 mg A single-arm prospective PK study of HIV-negative TGW taking FHT and daily PrEP.
- Primary Outcome Measures
Name Time Method Changes in plasma estradiol levels Measured at week 3 and week 9 of the study period Changes in plasma PrEP levels Week 9 through 12 1. Plasma TFV
2. Plasma FTC
3. Plasma TAFChanges in intracellular PrEP levels Week 9 through 12 1. PBMC TFV-DP levels
2. PBMC FTC-TP levels
- Secondary Outcome Measures
Name Time Method Changes in plasma testosterone levels Week 3 through 9
Trial Locations
- Locations (1)
Institute of HIV Research and Innovation (IHRI)
🇹🇭Bangkok, Pathumwan, Thailand