At a glance
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A Phase I Trial for the Evaluation of the Two-way Pharmacokinetic-pharmacodynamic (PD) Interaction of Gender Affirming Exogenous Estrogen (With Testosterone Suppression) on TDF/FTC PrEP in Transgender Women (TGW)
In Brief
A Phase 1 clinical trial evaluating Truvada alone, Truvada plus Leuprolide 11.25mg intramuscular injection, and 3 other interventions for HIV and 2 related conditions. Completed, enrolled 13 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
TDF/FTC 300 mg (milligrams) / 200 mg by mouth once daily
TDF/FTC 300mg/ 200 mg by mouth once daily Leuprolide 11.25 mg intramuscular injection once
TDF/FTC 300mg/ 200 mg by mouth once daily Estradiol 1 mg by mouth once daily
TDF/FTC 300mg/ 200 mg by mouth once daily Estradiol 3 mg by mouth twice daily
Estradiol 3 mg by mouth twice daily