NCT04590417

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

October 7, 2020

Last Update Submit

November 22, 2024

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (3)

  • Changes in plasma estradiol levels

    Measured at week 3 and week 9 of the study period

  • Changes in plasma PrEP levels

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

    Week 9 through 12

  • Changes in intracellular PrEP levels

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

    Week 9 through 12

Secondary Outcomes (1)

  • Changes in plasma testosterone levels

    Week 3 through 9

Study Arms (1)

20 HIV-negative TGW

OTHER

A single-arm prospective PK study of HIV-negative TGW taking FHT and daily PrEP.

Drug: Estradiol valerate 2 mg, cyproterone acetate 25 mg

Interventions

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.

20 HIV-negative TGW

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of HIV Research and Innovation (IHRI)

Bangkok, Pathumwan, 10330, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 40390323DERIVED

MeSH Terms

Interventions

EstradiolCyproterone Acetate

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsCyproteronePregnadienesPregnanesSteroids, Chlorinated

Study Officials

  • Siriporn Nonenoy, RN.MPH.

    Institute of HIV Research and Innovation (IHRI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 19, 2020

Study Start

January 24, 2022

Primary Completion

January 1, 2024

Study Completion

October 1, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

TH(1)