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NCT04593680
Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men
NA trial testing Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF) in Drug Interaction in 20 participants. Participants enrolled and being followed up; not accepting new ones.
1 October 2023
Quick facts
| Lead sponsor | Thai Red Cross AIDS Research Centre |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 24 January 2022 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (F/TDF) and emtricitabine 200 mg/tenofovir alafenamide 25 mg (F/TAF)
Conditions studied
- Drug Interaction — all drugs for Drug Interaction →
Sponsor
Thai Red Cross AIDS Research Centre — full company profile →
Who can join
Adults 18 to 40, female only, with Drug Interaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Hiransuthikul A, Thammajaruk N, Kerr S, Janamnuaysook R, et al · · 2025 · cited 1× · PMID 40195242 · DOI 10.1002/jia2.26445
Verify or expand the search:
- PubMed search for NCT04593680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Drug Interaction
Currently open trials in the same condition.
- NCT06717581 — Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older. · recruiting
- NCT05512169 — Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia · recruiting
- NCT04590417 — Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomit · NA · active not recruiting
Other Thai Red Cross AIDS Research Centre trials
Trials by the same sponsor.
- NCT04590417 — Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomit · NA · active not recruiting
- NCT05323695 — Implementation of a Depression Screening Intervention at a Transgender Health Clinic in Thailand · NA · completed
- NCT04505501 — Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection · Phase 2 · active not recruiting
- NCT04383769 — Differentiated Service Delivery for Antiretroviral Therapy · completed
- NCT01634607 — Bone Health and Vitamin D Status · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04593680 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Thai Red Cross AIDS Research Centre
- Last refreshed: 25 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04593680.
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