Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
NCT06005610 · View on ClinicalTrials.gov ↗
Study 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. The GET IT RiGHT trial aims to address concerns about drug-drug interactions (DDIs) between ART and FHT while providing access to hormonal therapy to TW living with HIV. Data suggest that access to FHT improves adherence to HIV treatment and decreases treatment interruptions. This is 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 will be on ART at entry and receive study-supplied 17-β estradiol for FHT for 48 weeks. The primary objectives of the study are 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 Studied
Interventions
- DRUG Estradiol
Study Locations (18)
California
- UCSD Antiviral Research Center CRS (701) — San Diego
- University of California, San Francisco HIV/AIDS CRS (801) — San Francisco
North Carolina
- Chapel Hill CRS (3201) — Chapel Hill
- Greensboro CRS (3203) — Greensboro
Other
- Barranco CRS (11301) — Lima
- Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (31784) — Chiang Mai
Colorado
- University of Colorado Hospital CRS (6101) — Aurora
District of Columbia
- Whitman-Walker Institute, Inc. CRS (31791) — Washington D.C.
Georgia
- The Ponce de Leon Center CRS (5802) — Atlanta
Maryland
- Johns Hopkins University CRS (201) — Baltimore
Missouri
- Washington University Therapeutics (WT) CRS (2101) — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2024-01-04 |
| Est. Completion | 2025-08-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06005610
The ClinicalTrials.gov registry entry for NCT06005610 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV I Infection appearing as the primary indexed condition, and to 1 intervention — of which Estradiol is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06005610 reports 18 study locations spanning 15 distinct geographic areas — top geographies include California, North Carolina, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06005610 about?
NCT06005610 is a clinical study titled "Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy". 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 d...
What is the current status of trial NCT06005610?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2024-01-04. Estimated completion is 2025-08-21.
What conditions does trial NCT06005610 study?
This clinical trial studies the following conditions: HIV I Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06005610?
The interventions under investigation include: Estradiol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06005610?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06005610 being conducted?
This trial has 18 study locations across California, Colorado, District of Columbia, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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