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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
Must not have
Use of systemic or anorectal immunomodulatory medications within 4 weeks of enrollment or planned use at any time during study participation
Current use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin [>81 mg], Non-steroidal anti-inflammatory drug [NSAIDs], or Pradaxa®)
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
No Placebo-Only Group

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.
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.
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
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I am 18 years old or older.
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I identify as a transgender woman.
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I can communicate in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used any immune system medications in the last 4 weeks and don't plan to during the study.
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I am currently taking medication that increases bleeding risk, like warfarin or high-dose aspirin.
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I have a lab result that shows a significant abnormality.
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I am not taking any PrEP medications.
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I have had serious bleeding in my stomach or intestines.
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I have had a serious heart or lung problem recently.
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I have a serious heart rhythm problem or kidney disease with low creatinine clearance.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,322 Previous Clinical Trials
14,874,138 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,317 Previous Clinical Trials
5,547,776 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
~1 spots leftby Mar 2025
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