Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women

NCT ID: NCT04590417

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2025-10-01

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.

Conditions

Drug Interaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

20 HIV-negative TGW

A single-arm prospective PK study of HIV-negative TGW taking FHT and daily PrEP.

Group Type: OTHER

Estradiol valerate 2 mg, cyproterone acetate 25 mg

Intervention Type: DRUG

The entire study period will be approximately 1 year, which will include around 2 months of document preparation, 5 months of recruitment, 3 months of follow-up, and 2 months of data analysis.

Interventions

Estradiol valerate 2 mg, cyproterone acetate 25 mg

The entire study period will be approximately 1 year, which will include around 2 months of document preparation, 5 months of recruitment, 3 months of follow-up, and 2 months of data analysis.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Thai nationality

2. Age 18-40 years old

3. Transgender women

4. HIV-negative

5. Body mass index 18.5-24.9 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. Signed the informed consent form

Exclusion Criteria

1. Known history of allergy to hormonal component to be used in the study

2. Male-to-female transgender who underwent orchiectomy

3. Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days

4. Use of injectable FHT in the past 3 months

5. Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen (HBsAg) positive

6. Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive

7. 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

8. Participant-reported active rectal infection requiring treatment

9. History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption

10. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Thai Red Cross AIDS Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siriporn Nonenoy, RN.MPH.

Role: STUDY_CHAIR

Institute of HIV Research and Innovation (IHRI)

Locations

Institute of HIV Research and Innovation (IHRI)

Bangkok, Pathumwan, Thailand

Countries

Thailand

References

Hiransuthikul A, Thammajaruk N, Kerr S, Janamnuaysook R, Nonenoy S, Hongchookiat P, Trichavaroj R, Tawon Y, Boonruang J, Teeratakulpisarn N, Cressey TR, Anderson PL, Phanuphak N; iFACT3 study team. No significant drug-drug interaction between oral TAF-based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT-3 study. J Int AIDS Soc. 2025 May;28(5):e26502. doi: 10.1002/jia2.26502.

Reference Type: DERIVED

PMID: 40390323 (View on PubMed)

Other Identifiers

iFACT 3

Identifier Type: -

Identifier Source: org_study_id