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.
Phase:
Phase 1
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)