Status:
COMPLETED
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
Lead Sponsor:
Thomas Jefferson University
Conditions:
Transgender Health
Gender Dysphoria
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy. Hormonal therapy typically consists of oral estradio...
Detailed Description
This study will consist of healthy transgender women volunteers randomized to a 1:1 sequence ("E" or "F") There are three periods and in each period there are one of three treatments Treatment A: Sin...
Eligibility Criteria
Inclusion
- Healthy self-identified transgender women (male-to-female) between 18-45 years old at the time of screening
- Have not undergone an orchiectomy
- Receiving oral estradiol and spironolactone for \>/= 3 months prior to study entry with a self-reported adherence to prescribed doses of \>/= 90%
- Agree to abstain from alcohol consumption throughout the duration of the study
- Be willing to briefly interrupt hormonal therapy prior to and during the study
- If on pre-exposure prophylaxis (PrEP) therapy containing tenofovir alafenamide or tenofovir disoproxil fumarate, willing to discontinue PrEP at least 2 weeks before study start and for the duration of the study
- Agree to use condoms for all sexual activity prior to the start and throughout the duration of the study
- Evidence of a personal signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
Exclusion
- Presence of clinically significant acute or chronic disease, that in the investigator's opinion, would compromise the participant's safety during the study
- Use of injectable or transdermal estradiol
- Use of any other hormonal replacement therapy, wit h the exception of oral estradiol and spironolactone
- Current use of any antiretroviral drug. This will not be exclusionary if participants reported discontinuing within 30 days of screening
- Creatinine clearance \</= 60 mL/min, as estimated by the Cockcroft-Gault equation
- Known anaphylactic or severe systemic reactions to any components of doravirine, lamivudine, or tenofovir disoproxil fumarate
- Positive HIV, hepatitis B or Hepatitis C virus at screening. Evidence of prior hepatitis B infection and immunity is not exclusionary. Positive hepatitis C antibody with negative viral load or documented antiviral hepatitis C treatment with one post treatment non-detectable hepatitis C viral load is not exclusionary
- Recent significant blood or plasma donation
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04283656
Start Date
January 4 2022
End Date
December 30 2022
Last Update
March 26 2025
Active Locations (1)
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1
Clinical Research Unit at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107