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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    20
  • sponsor
    Thai Red Cross AIDS Research Centre
Updated on 25 January 2021

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.

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.

Details
Condition Drug interaction, drug interactions, drug-drug interaction
Treatment Estradiol valerate 2 mg, cyproterone acetate 25 mg
Clinical Study IdentifierNCT04590417
SponsorThai Red Cross AIDS Research Centre
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 40 yrs?
Are you male?
Do you have Drug interaction?
Do you have any of these conditions: drug-drug interaction or Drug interaction or drug interactions?
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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note