← Back to Search

Antiretroviral Agent

PrEP + Hormone Therapy for HIV Prevention in Transgender Women

Phase 1
Recruiting
Led By Mark A Marzinke, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Self-identifying as a transgender woman
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 7-8, days 21-22, days 28-29, days 35-36, days 49-50
Awards & highlights

Study Summary

This trial is to study the best way to dose Truvada®, an oral medication that can be taken as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection, in transgender women who are also taking feminizing hormones.

Who is the study for?
This trial is for transgender women over 18, not currently on PrEP or GAHT with testosterone ≥200 ng/dL. Participants must be HIV-negative, English-speaking, and willing to avoid certain medications and activities before/after biopsies. They should agree to use condoms and participate in a directly observed study.Check my eligibility
What is being tested?
The study tests how Truvada as PrEP interacts with gender-affirming hormones in transgender women. It involves taking Truvada alone or with Leuprolide or low/high-dose Estradiol for about 4 months, including intensive sampling visits with colon biopsies and kidney function tests.See study design
What are the potential side effects?
Possible side effects include gastrointestinal discomfort from the biopsies, potential kidney issues due to medication interactions, hormone-related changes such as mood swings or physical alterations depending on the estradiol dosage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I identify as a transgender woman.
Select...
I can communicate in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 7-8, days 21-22, days 28-29, days 35-36, days 49-50
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 7-8, days 21-22, days 28-29, days 35-36, days 49-50 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in TFV-DP colon tissue concentration
Change in Tenofovir plasma concentration
Change in Tenofovir-Diphosphate PBMC concentration
Secondary outcome measures
Change in Serum luteinizing hormone (LH) concentration
Change in serum estradiol concentration
Change in serum follicular stimulating hormone (FSH)
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: PrEP plus Low Dose EstrogenExperimental Treatment1 Intervention
Truvada one tablet by mouth daily Estradiol 1 milligram by mouth daily x 2 weeks
Group II: PrEP plus High Dose EstrogenExperimental Treatment1 Intervention
Truvada one tablet by mouth daily Estradiol 6 milligrams (mg) by mouth daily x 2 weeks
Group III: PrEP plus Gonadotropin Releasing Hormone (GnRH) AgonistExperimental Treatment1 Intervention
Truvada one tablet by mouth daily Leuprolide 11.25 milligrams (mg) intramuscular (im) injection once
Group IV: High Dose EstrogenExperimental Treatment1 Intervention
Estradiol 6 mg by mouth daily x 2 weeks
Group V: Pre-Exposure Prophylaxis (PrEP) onlyActive Control1 Intervention
Truvada one tablet by mouth daily

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,145 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,217 Total Patients Enrolled
Mark A Marzinke, PhDPrincipal InvestigatorJohns Hopkins School of Medicine

Media Library

Truvada (Antiretroviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04760691 — Phase 1
HIV (Human Immunodeficiency Virus) Research Study Groups: Pre-Exposure Prophylaxis (PrEP) only, PrEP plus Gonadotropin Releasing Hormone (GnRH) Agonist, PrEP plus Low Dose Estrogen, PrEP plus High Dose Estrogen, High Dose Estrogen
HIV (Human Immunodeficiency Virus) Clinical Trial 2023: Truvada Highlights & Side Effects. Trial Name: NCT04760691 — Phase 1
Truvada (Antiretroviral Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04760691 — Phase 1

Frequently Asked Questions

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

Are there still openings for participants in this clinical trial?

"Clinicaltrials.gov attests that this medical examination is actively recruiting subjects. It was first submitted on March 1st 2021 and the details were last amended on March 8th 2022."

Answered by AI

What have been the findings of past investigations into Truvada alongside Leuprolide?

"Currently, 244 trials are assessing the impact of Truvada plus Leuprolide. Of those active studies, 70 have progressed to Phase 3 development. Despite being based in Duarte California, 8848 additional sites are running tests on this particular treatment combination."

Answered by AI

Has the combination of Truvada and Leuprolide been certified by the Food & Drug Administration?

"Due to the preliminary stages of this trial, the safety rating for Truvada plus Leuprolide is estimated at a 1. This can be attributed to limited evidence supporting efficacy and safety data."

Answered by AI

To what end are physicians typically prescribing Truvada plus Leuprolide?

"For advanced prostate cancer, the combination of Truvada and Leuprolide is commonly administered. In addition, this medication can be utilized to address moderate-severe symptoms, HIV infections with a viral load below 50 copies/ml on an existing antiretroviral regimen that needs replacing as well as for treatment failure cases."

Answered by AI

What results is the research team hoping to observe from this trial?

"The primary measure of success for this clinical trial will be the alteration in TFV-DP colon tissue concentration over a set time period. Secondary objectives include the observation of changes in serum luteinizing hormone (mIU/mL), free testosterone (ng/dL) and total testosterone concentrations (also reported as ng/dL)."

Answered by AI

To what extent is participation in the experiment limited?

"Correct. The information archived on clinicaltrials.gov indicates that the trial, which was initiated in March 2021, is actively seeking participants. Around 20 patients are required to be enrolled from one medical facility."

Answered by AI

Who else is applying?

What site did they apply to?
Johns Hopkins School of Medicine Drug Development Unit
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

The older I get the more I can’t stop thinking about being a female . I’m hoping this clinical trial can help me become me. I have not visited a doctor in years listed the last doctor I seen. My new phone number 1-224-416-9320 I’m willing to sign over my medical right decision-making to your trials. Promising never stop the procedure or asking for a reversal. Right and choices will be signed over to you. I’m willing to do anything feminizing, hormone ,surgical, Cervical transplant, pregnancy, I have never seen a doctor about this procedure. I have taken breast enlargement pills from gnc didn’t do anything. I’m always trying different herbs and supplements. And where female body shapers all the time hoping they reshape me. I always fantasize about renting a real female body having *** with my girlfriend just imagine somehow I broke the rules and now I’m stuck in her body nothing gets me more excited than that, I will volunteer for any procedure trials feminizing is wanting to try,,I want to be myself not stuck Where I am.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW
2021. "Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04760691.
All > Truvada
~4 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top