Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Drug Interaction

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of HIV Research and Innovation (IHRI)

Bangkok, Pathumwan, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Thai nationality
Age 18-40 years old
Female-to-Male transgender individual
HIV-negative
Body mass index 18.5-24.9 kg/m2
Negative urine pregnancy test
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

Exclusion criteria

Known history of allergy to hormonal component to be used in the study
Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
Use of injectable MHT in the past 3 months
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
History of myocardial infarction or coronary artery disease
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
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

Treatment and study plan

Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF)

Drug

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.

Primary outcomes

Changes in plasma TFV level

Time frame: 2 years
- 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]

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Registry information

Official study title

Institute of HIV Research and Innovation (IHRI)

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2025
First posted: Oct 20, 2020
Registry last updated: Nov 25, 2024

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.

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