Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
Status:
Recruiting
Trial end date:
2027-05-08
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)