NCT04760691 - Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

March 24, 2025

Study Completion Date

March 24, 2025

Conditions

HivProphylaxisTransgender

Interventions

DRUG

Truvada alone

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

DRUG

Truvada plus Leuprolide

TDF/FTC 300mg/ 200 mg by mouth once daily Leuprolide 11.25 mg im 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 twie daily

DRUG

Estradiol 6 mg alone

Estradiol 3 mg by mouth twice daily

Trial Locations (1)

Johns Hopkins School of Medicine Drug Development Unit, Baltimore

All Listed Sponsors

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Johns Hopkins University

OTHER