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

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ClinicalTrials.gov Identifier: NCT04590417
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drug Interaction Drug: Estradiol valerate 2 mg, cyproterone acetate 25 mg Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Institute of HIV Research and Innovation (IHRI)
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
20 HIV-negative TGW
A single-arm prospective PK study of HIV-negative TGW taking FHT and daily PrEP.
 Drug: Estradiol valerate 2 mg, cyproterone acetate 25 mg
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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in plasma estradiol levels [ Time Frame: Measured at week 3 and week 9 of the study period ]
  2. Changes in plasma PrEP levels [ Time Frame: Week 9 through 12 ]
    1. Plasma TFV
    2. Plasma FTC
    3. Plasma TAF

  3. Changes in intracellular PrEP levels [ Time Frame: Week 9 through 12 ]
    1. PBMC TFV-DP levels
    2. PBMC FTC-TP levels


Secondary Outcome Measures :
  1. Changes in plasma testosterone levels [ Time Frame: Week 3 through 9 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Thai nationality
  2. Age 18-40 years old
  3. Transgender women
  4. HIV-negative
  5. Body mass index 18.5-24.9 kg/m2
  6. Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft-Gault equation
  7. Alanine aminotransferase (ALT) ≤2.5 x ULN
  8. Signed the informed consent form

Exclusion Criteria:

  1. Known history of allergy to hormonal component to be used in the study
  2. Male-to-female transgender who underwent orchiectomy
  3. Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
  4. Use of injectable FHT in the past 3 months
  5. Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen (HBsAg) positive
  6. Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive

  7. 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
  8. Participant-reported active rectal infection requiring treatment
  9. History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption
  10. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590417


Contacts
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Contact: Nittaya Phanuphak, MD, PhD 881 8253544 nittaya.p@ihri.org
Contact: Rena Janamnuaysook, MBA 698 5164562 rena.j@ihri.org

Locations
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Thailand
Institute of HIV Research and Innovation (IHRI) Recruiting
Bangkok, Pathumwan, Thailand, 10330
Contact: Nittaya Phanuphak, MD, PhD    +662253 0996    nittaya.p@ihri.org   
Contact: Rena Janamnuaysook, MBA    +662253 0996    rena.j@ihri.org   
Principal Investigator: Nittaya Phanuphak, MD,PhD         
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
Investigators
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Study Chair: Rena Janamnuaysook, MBA Institute of HIV Research and Innovation (IHRI)
More Information
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Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT04590417    
Other Study ID Numbers: iFACT 3
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cyproterone Acetate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol
Polyestradiol phosphate
Cyproterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male