Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy

Stopped early · Phase 2

Conditions studied: HIV I Infection

In brief

Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and increased viral loads. Prior data suggest that access to FHT improves adherence to HIV treatment and decreases treatment interruptions. The Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy (GET IT RiGHT) trial aimed to address concerns about drug-drug interactions (DDIs) between ART and FHT while providing access to hormonal therapy to TW living with HIV. This was an open-label, non-randomized, 3-group trial of adult TW and other individuals identifying as female or transfeminine but with male sex assigned at birth living with HIV. Participants were on ART at entry and received study-supplied 17-β estradiol for FHT for up to 48 weeks. The primary objectives of the study were to 1) assess whether TW continue to achieve therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether serum estradiol concentrations on FHT (across a range of estradiol doses) vary between boosted and un-boosted ART regimens.

Key facts

Study ID

NCT06005610

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

93

Starts

2024-01-04

Expected to finish

2025-08-21

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Documentation of HIV-1 status.
• 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.
• 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.
• Desire to initiate or restart FHT, regardless of orchiectomy status.
• HIV-1 RNA <200 copies/mL at screening.
• 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.
• 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
• Serum estradiol level <75 pg/mL within 60 days prior to study entry.
• 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.
• Ability and willingness of participant to provide informed consent and ability and willingness of participant to undergo study procedures.

You may not qualify if…

• 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.
• Known liver impairment or disease.
• History of chronic hepatitis B virus (HBV) infection or active HBV infection.
• History of current active hepatitis C virus (HCV) infection.
• Prohibited medication use (including drugs with known or expected DDIs with FHT or ART) at time of study entry.
• 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.
• 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.
• Personal history of breast cancer. or known personal history of breast cancer (BRCA) gene.
• Known or a history of testicular cancer.
• Known or a history of gall bladder disease.
• Known or suspected pituitary adenoma.
• Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
• 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).
• 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.
• Presence of any other medical condition that would preclude FHT administration for safety reasons, in the opinion of the site investigator.

Where it is running

• UCSD Antiviral Research Center CRS (701) — San Diego, California, United States
• University of California, San Francisco HIV/AIDS CRS (801) — San Francisco, California, United States
• University of Colorado Hospital CRS (6101) — Aurora, Colorado, United States
• Whitman-Walker Institute, Inc. CRS (31791) — Washington D.C., District of Columbia, United States
• The Ponce de Leon Center CRS (5802) — Atlanta, Georgia, United States
• Johns Hopkins University CRS (201) — Baltimore, Maryland, United States
• Washington University Therapeutics (WT) CRS (2101) — St Louis, Missouri, United States
• New Jersey Medical School Clinical Research Center CRS (31786) — Newark, New Jersey, United States
• Weill Cornell Uptown CRS (site 7803) — New York, New York, United States
• Chapel Hill CRS (3201) — Chapel Hill, North Carolina, United States
• Greensboro CRS (3203) — Greensboro, North Carolina, United States
• Case CRS (2501) — Cleveland, Ohio, United States
• Vanderbilt Therapeutics CRS (3652) — Nashville, Tennessee, United States
• Houston AIDS Research Team CRS (31473) — Houston, Texas, United States
• Nutrición-Mexico CRS (32078) — Mexico City, Tlalpan, Mexico
• Barranco CRS (11301) — Lima, Peru
• Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (31802) — Bangkok, Patumwan, Thailand
• Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (31784) — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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