Drug Interaction Clinical Trial
Official title:
Institute of HIV Research and Innovation (IHRI)
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Institute of HIV Research and Innovation (IHRI) | Bangkok | Pathumwan |
Lead Sponsor | Collaborator |
---|---|
Thai Red Cross AIDS Research Centre |
Thailand,
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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