NCT04590417Active, not recruiting
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
Institute of HIV Research and Innovation (IHRI)
Source: ClinicalTrials.gov · Last updated 25 Nov 2024
Brief summary (registry, in English)
Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among transgender women (TGW). New strategies for PrEP among TGW who use FHT are urgently needed. Because tenofovir alafenamide (TAF) can achieve higher intracellular TFV-DP levels with lower tenofovir plasma concentrations, it is promising that both plasma TFV and intracellular TFV-DP levels might not be significantly affected by FHT. The current study aims to determine the pharmacokinetics DDI between FHT and F/TAF-based PrEP among TGW.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 7 Oct 2020
- Start date
- 24 Jan 2022
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Diseases
- HIV
- NCT number
- NCT04590417
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 24 Jan 2022 to the primary completion date, 1 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of any of the following:
- Anticonvulsants: carbamazepine, felbamate, oxcarbazepine, phenytoin, phenobarbital, primidone or topiramate
- Herbs: gingko biloba, St John's wort or milk thistle
- Anti-infective agents: azole antifungals, macrolides, griseofulvin, protease inhibitors, rifampicin or rifabutin
- Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Other illness
- Known history of allergy to hormonal component to be used in the study
- 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
- Participant-reported active rectal infection requiring treatment
- History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption
Other
- Male-to-female transgender who underwent orchiectomy
- Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
- Use of injectable FHT in the past 3 months
Who the study is looking for
- Thai nationality
- Age 18-40 years old
- Transgender women
- HIV-negative
- Body mass index 18.5-24.9 kg/m2
- 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
Age in the registry: 18 years to 40 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of HIV Research and Innovation (IHRI) Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.