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Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy

NCT06005610 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2026-04-08

Study results available
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Summary

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.

Conditions

  • HIV I Infection

Interventions

DRUG

Estradiol

Oral 17-β estradiol 2 mg once daily initiated immediately following entry. At weeks 4, 12, 24, and 36, study clinicians may have titrated 17-β estradiol in 2 mg increments to achieve the desired participant goals and target hormone concentrations, as measured locally at each visit.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jordan E. Lake, MD, MSc · Houston AIDS Research Team CRS

  • Kimberly K. Scarsi, PharmD, MS, FCCP · University of Nebraska

  • Jorge A. Gallardo-Cartagena, MD · Barranco CRS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-04
Primary Completion
2025-08-21
Completion
2025-08-21
FDA Drug
Yes

Countries

  • United States
  • Mexico
  • Peru
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005610 on ClinicalTrials.gov