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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

GET IT RIgHT Trial 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.Check my eligibility

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.See study design

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.

GET IT RIgHT Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and study entry and weeks 4, 12, 24, 36, 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Absolute change in maximum hip circumference

Absolute change in minimum waist circumference

Absolute change in waist-hip ratio measured

+13 more

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175

18%

Breast Tenderness

15%

Cramps

15%

Itchiness at patch site

12%

Headaches

Nausea

Acne

Lower Back Pain

Hot Flashes

Menstrual Bleeding

Bloating

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Perimenopausal Women, Depressed

Perimenopausal Women, Non-depressed

GET IT RIgHT 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,147 Total Patients Enrolled

Jordan E. Lake, MD, MScStudy ChairHouston AIDS Research Team CRS

2 Previous Clinical Trials

109 Total Patients Enrolled

Kimberly K. Scarsi, PharmD, MS, FCCPStudy ChairUniversity of Nebraska

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enlisting participants for this trial?

"Contrary to expectations, this clinical trial is not currently recruiting participants; the listing for which was last updated on September 7th 2023. However, 95 other studies can be found actively searching for enrollees at present."

Answered by AI

What dangers should be taken into consideration when using Group 1: BIC-treated for patients?

"Although Group 1: BIC-treated has no clinical data demonstrating efficacy, the pre-existing evidence of safety earned a rating of 2 on our scale."

Answered by AI

In which locations can patients access this clinical trial?

"This study is being conducted at multiple sites, including the University of California San Francisco HIV/AIDS CRS (801) in San Francisco, Colorado; the University of Colorado Hospital CRS (6101) in Aurora, District of Columbia and Whitman-Walker Institute Inc. CRS (31791), located in Washington Maryland. Additionally there are 24 other potential locations for enrolment."

Answered by AI

What objectives are researchers hoping to fulfill with this investigation?

"This clinical trial will be monitored from Study Entry to Weeks 4, 12, 24, 36 and 48. The primary outcome of the study is Percentage of Participants with ART Analyte trough concentration (Ctrough) above drug-specific threshold. Secondary outcomes include Percentage of Participants with TFV-DP, FTC-TP and 3TC-TP trough concentrations surpassing a preconfigured cut off point as well as any adverse events related to 17-β estradiol that are reported according to International Conference on Harmonization standards along with new occurrences of CAD/CVD cancer, DM/preDM or vascular events associated with 17- β estrad"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy

2024. "Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005610.

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