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

Drug Interaction Clinical Trial

Official title:

Institute of HIV Research and Innovation (IHRI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593680
• Other study ID #: iMACT
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Drug Interaction

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