Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women

Completed · Phase 1 · Has a placebo group

Conditions studied: Transgender Health, Gender Dysphoria, Transgender Women, Human Immunodeficiency Virus

In brief

Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy. Hormonal therapy typically consists of oral estradiol and spironolactone, which induce drug-metabolizing enzymes after prolonged administration. This study evaluates the bi-directional potential drug interaction between the antiretroviral drug, doravirine, when co-administered with estradiol and spironolactone.

Key facts

Study ID

NCT04283656

Run by

Thomas Jefferson University

People needed

8

Starts

2022-01-04

Expected to finish

2022-12-30

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Unit at Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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