Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
Public ClinicalTrials.gov record NCT06005610. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06005610
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 93 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 3, 2024
- Primary completion
- Aug 20, 2025
- Completion
- Aug 20, 2025
- Last update posted
- Apr 7, 2026
2024 – 2025
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD Antiviral Research Center CRS (701) | San Diego | California | 92103 | — |
| University of California, San Francisco HIV/AIDS CRS (801) | San Francisco | California | 94110 | — |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | — |
| Whitman-Walker Institute, Inc. CRS (31791) | Washington D.C. | District of Columbia | 20005 | — |
| The Ponce de Leon Center CRS (5802) | Atlanta | Georgia | 30308 | — |
| Johns Hopkins University CRS (201) | Baltimore | Maryland | 21205 | — |
| Washington University Therapeutics (WT) CRS (2101) | St Louis | Missouri | 63110-1010 | — |
| New Jersey Medical School Clinical Research Center CRS (31786) | Newark | New Jersey | 07103 | — |
| Weill Cornell Uptown CRS (site 7803) | New York | New York | 10065 | — |
| Chapel Hill CRS (3201) | Chapel Hill | North Carolina | 27599-7215 | — |
| Greensboro CRS (3203) | Greensboro | North Carolina | 27401 | — |
| Case CRS (2501) | Cleveland | Ohio | 44106 | — |
| Vanderbilt Therapeutics CRS (3652) | Nashville | Tennessee | 37204 | — |
| Houston AIDS Research Team CRS (31473) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06005610, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06005610 live on ClinicalTrials.gov.