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Completed

NCT Number: NCT04283656

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

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.

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Key information

Conditions

Transgender Health Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Gender Dysphoria Genital Diseases HIV Infections Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexual Dysfunctions, Psychological Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Transgender Women Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Unit at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone

The primary outcome measures are the drug concentrations

The primary comparisons are geometric mean ratios of drugs with potential perpetrators of drug interactions using a crossover method

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Doravirine/Lamivudine/Tenofovir

Drug

100mg/300mg/300mg orally for one dose, daily

Other names: Delstrigo

Spironolactone 100mg

Drug

200mg orally for two doses, twice-daily

Other names: Aldactone

Estradiol 2mg

Drug

4mg orally for two doses, twice-daily

Placebo

Other

Placebo for one dose, daily

Primary outcomes

  1. Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)

    Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants

    Doravirine AUC derived from plasma sampling with geometric mean ratio compared between treatment arms

  2. Doravirine Maximum Concentration (Cmax)

    Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants

    Doravirine maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms

  3. Doravirine Trough Concentration (C24)

    Time frame: 24 hours post-dose for all participants

    Doravirine observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms

  4. Tenofovir Disoproxil Fumarate Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)

    Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants

    Tenofovir AUC derived from plasma sampling with geometric mean ratio compared between treatment arms

  5. Tenofovir Disoproxil Fumarate Maximum Concentration (Cmax)

    Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants

    Tenofovir maximum observed concentration during the dosing interval

  6. Tenofovir Disoproxil Fumarate Trough Concentration (C24)

    Time frame: 24 hours post-dose for all participants

    Tenofovir observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms

  7. Estradiol Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)

    Time frame: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants

    Estradiol area under the plasma concentration versus time curve from 0 hours to infinity (AUC) derived from plasma sampling

  8. Estradiol Maximum Concentration (Cmax)

    Time frame: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants

    Estradiol maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms

  9. Estradiol Trough Concentration (C12)

    Time frame: 12 hours post-dose for all participants

    Estradiol observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

A Prospective, Randomized, Three-period Crossover, Interaction Study to Evaluate the Pharmacokinetics of Doravirine and Tenofovir Disoproxil Fumarate Co-administered With Cross-sex Hormonal Therapy in Adult HIV-negative Transgender Women

Acronym: IDENTIFY

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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