Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of HIV I Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Log-transformed trough concentrations (Ctrough) in ng/mL of the analytes BIC, DTG, and DRV from plasma samples collected 22-26 hours post ART dose, measured over 48 weeks. Geometric ratios will be calculated as the log of Ctrough of the ART analyte at each dose of 17-β estradiol - log of Ctrough of that same ART analyte at baseline. If multiple observations are available at the same estradiol dose, the first sampled qualifying steady-state trough concentration (based on calendar time) taken will
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 |
What the finished NCT06005610 record still lists
NCT06005610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 2,086-participant average among 5 other HIV I Infection trials with a reported enrollment target (96% lower).
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 lists 18 locations in 15 states (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.
Learn More About Clinical Trials
Similar trials for HIV I Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments
ACTIVE NOT RECRUITING · NA
-
To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
COMPLETED · Phase 1
-
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
COMPLETED · Phase 1
-
Charlotte Retention in Care Study
COMPLETED
-
Acute Effects of TCIG vs ECIG in PLWH
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02203526 · 93 participants · Phase 1
Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma
- NCT03089554 · 93 participants · Phase 2
Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
- NCT05000021 · 93 participants · NA
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
- NCT05489887 · 93 participants · Phase 2
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI