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Hormone Therapy
Estradiol Therapy for HIV in Transgender Women (GET IT RIgHT Trial)
Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study entry and weeks 4, 12, 24, 36, 48
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help transgender women living with HIV access feminizing hormone therapy and determine the best HIV treatment regimens for them.
Who is the study for?
This trial is for adult transgender women and transfeminine individuals living with HIV who have been on antiretroviral therapy (ART) for at least 24 weeks. They must have a stable viral load, normal organ function tests, no history of certain cancers or clotting disorders, and not be taking other hormone therapies outside the study.
What is being tested?
The GET IT RiGHT trial studies how well HIV treatment works when taken alongside feminizing hormone therapy (FHT), specifically estradiol. It checks if ART maintains its effectiveness and measures estradiol levels in participants over a period of 48 weeks.
What are the potential side effects?
Potential side effects from estradiol may include mood changes, weight gain, blood clots, elevated liver enzymes, nausea, headaches, and increased risk of certain types of cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study entry and weeks 4, 12, 24, 36, 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study entry and weeks 4, 12, 24, 36, 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Geometric Mean Ratio of ART Analytes BIC, DTG, and DRV trough concentrations (Ctrough) in plasma at each received dose of oral 17-β estradiol
Percentage of Participants with ART Analyte trough concentration (Ctrough) above drug-specific threshold
Trough serum total estradiol assessed at each received dose of oral 17-β estradiol as quantified via batch testing at central lab.
Secondary study objectives
Absolute change in maximum hip circumference
Absolute change in minimum waist circumference
Absolute change in waist-hip ratio measured
+13 moreSide effects data
From 2018 Phase 4 trial • 64 Patients • NCT0225517518%
Breast Tenderness
15%
Cramps
15%
Itchiness at patch site
12%
Headaches
9%
Nausea
6%
Acne
6%
Lower Back Pain
6%
Hot Flashes
6%
Menstrual Bleeding
6%
Bloating
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Depressed
Perimenopausal Women, Non-depressed
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3: Boosted DRV-treatedExperimental Treatment1 Intervention
Participants taking any regimen containing darunavir plus cobicistat (DRV/c)
Group II: Group 2: DTG-treatedExperimental Treatment1 Intervention
Participants taking dolutegravir (DTG) once daily + tenofovir disoproxil fumarate (TDF) + (FTC or lamivudine \[3TC\])
Group III: Group 1: BIC-treatedExperimental Treatment1 Intervention
Participants taking bictegravir (BIC) + tenofovir alafenamide (TAF) + emtricitabine (FTC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol
2008
Completed Phase 4
~3960
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,648 Total Patients Enrolled
Kimberly K. Scarsi, PharmD, MS, FCCPStudy ChairUniversity of Nebraska
Jorge A. Gallardo-Cartagena, MDStudy ChairBarranco CRS
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