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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 HIV-negative TGM will take daily TDF/FTC-based PrEP | Experimental | MHT will be initiated on week 0 and will be last administered on week 12. PrEP will be initiated on week 6 and continued without interruption. MHT: Intramuscular testosterone enanthate 200 mg bi-weekly, which is the treatment of choice for MHT in the Pribta Clinic, will be provided to all participants. PrEP: Fixed-dose combination of emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF) will be provided for arm 1 and 2, respectively. Pharmacokinetic measurement of study drug Two full pharmacokinetic (PK) measurements will be performed. Samples collected will include: plasma for testosterone, emtricitabine (FTC) and tenofovir (TFV), with an additional tenofovir alafenamide (TAF). |
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| 20 HIV-negative TGM will take daily F/TAF-based PrEP | Experimental | MHT will be initiated on week 0 and will be last administered on week 12. PrEP will be initiated on week 6 and continued without interruption. MHT: Intramuscular testosterone enanthate 200 mg bi-weekly, which is the treatment of choice for MHT in the Pribta Clinic, will be provided to all participants. PrEP: Fixed-dose combination of emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF) will be provided for arm 1 and 2, respectively. Pharmacokinetic measurement of study drug Two full pharmacokinetic (PK) measurements will be performed. Samples collected will include: arm 2, measurement; and peripheral blood mononuclear cells (PBMC) for emtricitabine-triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) intracellular quantification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma TFV level |
| 2 years |
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Inclusion Criteria:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of HIV Research and Innovation (IHRI) | Bangkok | Pathumwan | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40195242 | Derived | 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; iMACT study team. Exploring potential drug-drug interactions between masculinizing hormone therapy and oral pre-exposure prophylaxis (F/TDF and F/TAF) among transgender men (iMACT study): a randomized, open-label pharmacokinetic study in Thailand. J Int AIDS Soc. 2025 Apr;28(4):e26445. doi: 10.1002/jia2.26445. |
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An open-label, randomized, two-arm prospective PK study of HIV-negative TGM taking MHT and daily PrEP:
Arm 1: Twenty HIV-negative TGM will take daily TDF/FTC-based PrEP
Arm 2: Twenty HIV-negative TGM will take daily F/TAF-based PrEP
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|
| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| C442442 | tenofovir alafenamide |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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