Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women
NCT03060785 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2018-07-18
Summary
This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy.
Conditions
- HIV Prevention
Interventions
- DRUG
-
Tenofovir Disoproxil Fumarate/Emtricitabine
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Craig Hendrix, MD · Johns Hopkins University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-03-08
- Primary Completion
- 2018-05-31
- Completion
- 2018-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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