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Drug InteractionNCT04590417

Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women

A study testing Estradiol valerate 2 mg, cyproterone acetate 25 mg in people with Drug Interaction, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Drug Interaction
What is being tested?
Estradiol valerate 2 mg, cyproterone acetate 25 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteThailand
Study dates
24 Jan 2022to 1 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Known history of allergy to hormonal component to be used in the study
  • 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
  • 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
Show all 13Show fewer
  • 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
  • Participant-reported active rectal infection requiring treatment
  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Institute of HIV Research and Innovation (IHRI)

    Bangkok, Pathumwan, 10330

Other trials in Thailand

About this study

Official title: Institute of HIV Research and Innovation (IHRI)

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.

Read the detailed description

Two full pharmacokinetic (PK) measurements will be performed. Samples collected will include: plasma for estradiol (E2), emtricitabine (FTC), tenofovir (TFV), and tenofovir alafenamide (TAF) measurement; and peripheral blood mononuclear cells (PBMC) for emtricitabine-triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) intracellular quantification.

Being tested
Estradiol valerate 2 mg, cyproterone acetate 25 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estradiol valerate 2 mg, cyproterone acetate 25 mgDrug

    The entire study period will be approximately 1 year, which will include around 2 months of document preparation, 5 months of recruitment, 3 months of follow-up, and 2 months of data analysis.

Study groups in NCT04590417
Study groupRoleWhat they receive
20 HIV-negative TGWOtherA single-arm prospective PK study of HIV-negative TGW taking FHT and daily PrEP.
Receives: Drug: Estradiol valerate 2 mg, cyproterone acetate 25 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in plasma estradiol levels

    Measured: Measured at week 3 and week 9 of the study period

  2. Changes in plasma PrEP levels

    1. Plasma TFV
    2. Plasma FTC
    3. Plasma TAF

    Measured: Week 9 through 12

  3. Changes in intracellular PrEP levels

    1. PBMC TFV-DP levels
    2. PBMC FTC-TP levels

    Measured: Week 9 through 12

Secondary outcomes (1)

  1. Changes in plasma testosterone levels

    Measured: Week 3 through 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start24 Jan 2022
  3. Primary completion1 Jan 2024
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04590417
Sponsor's protocol ID
iFACT 3
Status last verified
Nov 2024
First submitted
7 Oct 2020
Last updated
25 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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; iFACT3 study team. No significant drug-drug interaction between oral TAF-based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT-3 study. J Int AIDS Soc. 2025 May;28(5):e26502. doi: 10.1002/jia2.26502.

    PubMed 40390323

Questions about this trial

What is this clinical trial studying?

A study testing Estradiol valerate 2 mg, cyproterone acetate 25 mg in people with Drug Interaction, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in plasma estradiol levels (time frame: Measured at week 3 and week 9 of the study period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04590417, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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