HIV PrEP and hormones: small study aims to Fine-Tune dosing for transgender women

NCT ID NCT04760691

Completed Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial from Johns Hopkins University enrolled 13 transgender women to see how the HIV prevention drug Truvada interacts with feminizing hormones like estrogen. Participants took Truvada alone and then with added hormones or a testosterone blocker. The goal was to measure drug levels in blood and tissues to find the best dosing strategy. The study did not test whether Truvada actually prevents HIV, but rather how hormones might affect its concentration in the body.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Truvada (tenofovir disoproxil fumarate/emtricitabine) with or without leuprolide or estradiol
What this could lead to: If successful, this could help doctors determine the right dose of HIV PrEP for transgender women taking feminizing hormones, improving HIV prevention in this group.
What could go wrong: This was a very small, early-phase trial with only 13 participants, so results may not apply to everyone. It focused on drug levels, not actual HIV prevention, so more research is needed.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV PROPHYLAXIS TRANSGENDER

Contacts and locations

Locations

Johns Hopkins School of Medicine Drug Development Unit

Baltimore, Maryland, 21287, United States

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