Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW

Summary

This is a research study to determine the best way to dose Truvada®, an oral medication licensed to be taken as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection, in transgender women who are also taking feminizing hormones. The duration of the study is about 4 months, and involves a screening visit, a baseline visit with colon biopsies and kidney function testing, and several outpatient visits, including 5 intensive sampling visits that last about 9 hours and involve colon biopsies, kidney function testing and other blood specimen collections.

After the baseline visit, participants will start on PrEP, daily Truvada® pills, and will continue on the Truvada® for 5 weeks. Participants will then receive either an injection of Lupron, oral low-dose estradiol or oral high-dose estradiol, which will be taken along with the Truvada® PrEP for 1-2 weeks before returning for an intensive sampling visit.

Conditions

• HIV
• Prophylaxis
• Transgender

Interventions

DRUG

Truvada alone

TDF/FTC 300 mg (milligrams) / 200 mg by mouth once daily

DRUG

Truvada plus Leuprolide 11.25mg intramuscular injection

TDF/FTC 300mg/ 200 mg by mouth once daily Leuprolide 11.25 mg intramuscular injection once

DRUG

Truvada plus Estradiol 1 mg

TDF/FTC 300mg/ 200 mg by mouth once daily Estradiol 1 mg by mouth once daily

DRUG

Truvada plus Estradiol 6 mg

TDF/FTC 300mg/ 200 mg by mouth once daily Estradiol 3 mg by mouth twice daily

DRUG

Estradiol 6 mg alone

Estradiol 3 mg by mouth twice daily

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Mark A Marzinke, PhD · Johns Hopkins School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2025-03-24

Completion

2025-03-24

FDA Drug

Yes

Countries

• United States

Study Locations