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NCT06005610 · ClinicalTrials.gov registry record · Phase 2
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
A Phase 2 study of HIV I Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 18
- Study locations
NCT06005610 is a Phase 2 study of HIV I Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 93 participants, below the 2,086-participant average among 5 other HIV I Infection trials with a reported enrollment target (96% lower). The trial reports 18 study locations across 15 states.
The verdict
NCT06005610, a Phase 2 study of HIV I Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 18
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,086-participant average among 5 other HIV I Infection trials with a reported enrollment target (96% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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.
NCT06005610 reports 18 study locations spanning 15 distinct geographic areas - top geographies include California, North Carolina, Other.
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.
What interventions are being tested in trial NCT06005610?
The interventions under investigation include: Estradiol (DRUG).
Who is sponsoring clinical trial NCT06005610?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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