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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04593680
Other study ID # iMACT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date October 1, 2025

Study information

Verified date April 2022
Source Thai Red Cross AIDS Research Centre
Contact Nittaya Phanuphak, MD, PhD
Phone 881 8253544
Email nittaya.p@ihri.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are currently no published studies addressing drug-drug interactions (DDI) between masculinizing hormone therapy (MHT) and pre-exposure prophylaxis (PrEP) among transgender men (TGM). This could lead to concerns and subsequent prioritizing MHT over PrEP among TGM. Because tenofovir alafenamide (TAF) can achieve higher intracellular tenofovir diphosphate (TFV-DP) levels with lower tenofovir plasma concentrations, it is promising that both plasma tenofovir (TFV) and intracellular TFV-DP levels might not be significantly affected by MHT. The current study aims to determine the pharmacokinetics (PK) DDI between MHT and daily PrEP among TGM.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 1, 2025
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Thai nationality 2. Age 18-40 years old 3. Female-to-Male transgender individual 4. HIV-negative 5. Body mass index 18.5-24.9 kg/m2 6. Negative urine pregnancy test 7. Calculated creatinine clearance (CrCl) =60 mL/min, as estimated by the Cockcroft-Gault equation 8. Alanine aminotransferase (ALT) =2.5 x ULN 9. Signed the informed consent form Exclusion Criteria: 1. Known history of allergy to hormonal component to be used in the study 2. Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days 3. Use of injectable MHT in the past 3 months 4. Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen [HBsAg] positive 5. Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive 6. History of myocardial infarction or coronary artery disease 7. Current use of any of the following: - Anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, or phenobarbital - Herbs: gingko biloba, St John's wort or milk thistle - Anti-infective agents: protease inhibitors, rifampicin or rifabutin 8. History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption 9. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF)
The first full PK measurement of MHT will be performed starting at week 4 and end at week 6 to assess the steady-state plasma PK of testosterone in the absence of PrEP. The second PK measurement of MHT will be performed starting at week 12 and end at week 14 to assess plasma PK of testosterone in the presence of both MHT and PrEP. The first full PK measurement of PrEP will be performed at week 12 to assess the steady-state plasma PK of FTC, TFV, and TAF; and intracellular PBMC FTC-TP and TFV-DP in the presence of both MHT and PrEP. The second measurement of PrEP will be performed at week 16 to assess plasma PK of FTC, TFV, and TAF; and intracellular PBMC FTC-TP and TFV-DP in the absence of MHT.

Locations

Country Name City State
Thailand Institute of HIV Research and Innovation (IHRI) Bangkok Pathumwan

Sponsors (1)

Lead Sponsor Collaborator
Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in plasma TFV level Changes in plasma testosterone levels [Time Frame: Measured at week 4 and week 12 of the study period]
Changes in plasma TFV levels [Time Frame: Measured at week 12 and week 16 of the study period]
Changes in plasma emtricitabine (FTC) levels [Time Frame: Measured at week 12 and week 16 of the study period]
Changes in plasma TAF levels [Time Frame: Measured at week 12 and week 16 of the study period]
Changes in peripheral blood mononuclear cell TFV-DP levels [Time Frame: Measured at week 12 and week 16 of the study period]
Changes in peripheral blood mononuclear cell (PBMC) emtricitabine triphosphate (FTC-TP) levels [Time Frame: Measured at week 12 and week 16 of the study period]
2 years
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