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Hormone therapy and HIV drugs: a delicate balance for transgender women

NCT ID NCT06005610

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how feminizing hormone therapy (estradiol) interacts with HIV medications in transgender women living with HIV. It included 93 participants who were already on HIV treatment and gave them standardized estradiol doses for up to 48 weeks. The goal was to see if hormone therapy affects HIV drug levels and vice versa, to help create better treatment guidelines. The study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral 17-β estradiol (estrogen hormone therapy)
What this could lead to
If successful, this could help doctors choose HIV medications that work well alongside feminizing hormone therapy, improving health outcomes for transgender women with HIV.
What could go wrong
The study was terminated early, so results are limited. It was also a small, non-randomized trial, meaning findings may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

93 people

The number who actually took part.

Started

Jan 2024

Finished

Aug 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Documentation of HIV-1 status. 2. On ART for at least 24 weeks prior to study entry. Regimen changes within the 24 weeks prior to study entry are acceptable, but candidates must have been on a stable regimen for at least 28 days prior to study entry. 3. On BIC/FTC/TAF, DTG/TDF/FTC or 3TC, or DRV/c-containing ART for at least 28 days prior to study entry (single tablet regimen not required), and with no plans to change ART regimen over the study duration of 48 weeks. 4. Desire to initiate or restart FHT, regardless of orchiectomy status. 5. HIV-1 RNA \<200 copies/mL at screening. 6. HIV-1 RNA \<400 copies/mL available through routine clinical care between 24 and 96 weeks prior to study entry and while on ART. The HIV-1 RNA must be the most recent value obtained between 24 and 96 weeks prior to study entry. 7. The following laboratory values obtained within 60 days prior to study entry * Hemoglobin ≥9.0 g/dL * Platelet count ≥75,000/mm3 * Estimated Glomerular Filtration Rate (eGFR) ≥30 mL/min/1.73m2 if on or switching to TAF, ≥50 mL/min/1.73m2 if on or switching to TDF without cobicistat, or ≥70 mL/min/1.73m2 if on or switching to TDF in combination with cobicistat, calculated using standardized equation for eGFR * Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase are within normal range per local laboratory range * Prolactin \<25 ng/dL 8. Serum estradiol level \<75 pg/mL within 60 days prior to study entry. 9. Willingness to avoid the use of prescribed, non-study provided FHT and non-prescribed FHT during the study period, and no planned use of prescribed or non-prescribed anti-androgens for the first 24 weeks of the study. 10. Ability and willingness of participant to provide informed consent and ability and willingness of participant to undergo study procedures. Exclusion Criteria: 1. Known clotting disorders, active deep vein thrombosis (DVT), pulmonary embolism (PE), or history of these conditions, active arterial thromboembolic disease (e.g., stroke, myocardial infarction), or history of these conditions. 2. Known liver impairment or disease. 3. History of chronic hepatitis B virus (HBV) infection or active HBV infection. 4. History of current active hepatitis C virus (HCV) infection. 5. Prohibited medication use (including drugs with known or expected DDIs with FHT or ART) at time of study entry. 6. Receipt of any estrogen therapy within 14 days prior to study entry for persons on oral FHT, or within 30 days prior to entry for persons on injectable FHT. 7. Known HIV-1 resistance mutations that would preclude remaining on current ART or a switch to a study regimen, in the opinion of the site investigator. 8. Personal history of breast cancer. or known personal history of breast cancer (BRCA) gene. 9. Known or a history of testicular cancer. 10. Known or a history of gall bladder disease. 11. Known or suspected pituitary adenoma. 12. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation. 13. Suicidal ideation in the past 30 days or suicide attempt in the past 90 days, as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS). 14. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry. Stable (in the opinion of the site investigator) treatments for chronic comorbidities are allowed. 15. Presence of any other medical condition that would preclude FHT administration for safety reasons, in the opinion of the site investigator.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV I infection

Contacts and locations

Locations

  • Barranco CRS (11301)

    Lima, 4, Peru

  • Case CRS (2501)

    Cleveland, Ohio, 44106, United States

  • Chapel Hill CRS (3201)

    Chapel Hill, North Carolina, 27599-7215, United States

  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (31784)

    Chiang Mai, 50200, Thailand

  • Greensboro CRS (3203)

    Greensboro, North Carolina, 27401, United States

  • Houston AIDS Research Team CRS (31473)

    Houston, Texas, 77030, United States

  • Johns Hopkins University CRS (201)

    Baltimore, Maryland, 21205, United States

  • New Jersey Medical School Clinical Research Center CRS (31786)

    Newark, New Jersey, 07103, United States

  • Nutrición-Mexico CRS (32078)

    Mexico City, Tlalpan, 14080, Mexico

  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (31802)

    Bangkok, Patumwan, 10330, Thailand

  • The Ponce de Leon Center CRS (5802)

    Atlanta, Georgia, 30308, United States

  • UCSD Antiviral Research Center CRS (701)

    San Diego, California, 92103, United States

  • University of California, San Francisco HIV/AIDS CRS (801)

    San Francisco, California, 94110, United States

  • University of Colorado Hospital CRS (6101)

    Aurora, Colorado, 80045, United States

  • Vanderbilt Therapeutics CRS (3652)

    Nashville, Tennessee, 37204, United States

  • Washington University Therapeutics (WT) CRS (2101)

    St Louis, Missouri, 63110-1010, United States

  • Weill Cornell Uptown CRS (site 7803)

    New York, New York, 10065, United States

  • Whitman-Walker Institute, Inc. CRS (31791)

    Washington D.C., District of Columbia, 20005, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.