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NCT04760691 · ClinicalTrials.gov registry record · Phase 1
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04760691: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT04760691 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04760691, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study 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.
Primary Outcome
Plasma TFV Cmax was defined as the highest observed concentration during the 24 hour (h) dosing interval and determined via non-compartmental analyses. Median maximum concentrations with interquartile ranges (IQR) were determined. Differences in TFV Cmax concentrations were determined for each participant, and each dosing period was compared to the PrEP Only Dosing Period. The median intra-individual difference in TFV Cmax, with IQRs, was calculated.
Interventions
- DRUG Truvada alone
- DRUG Truvada plus Leuprolide 11.25mg intramuscular injection
- DRUG Truvada plus Estradiol 1 mg
- DRUG Truvada plus Estradiol 6 mg
- DRUG Estradiol 6 mg alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2025-03-24 |
| Phase | Phase 1 |
What the finished NCT04760691 record still lists
NCT04760691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Truvada alone is the first listed.
NCT04760691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04760691 about?
NCT04760691 is a clinical study titled "Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW". 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 screenin...
What is the current status of trial NCT04760691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-03-01. Estimated completion is 2025-03-24.
What interventions are being tested in trial NCT04760691?
The interventions under investigation include: Truvada alone (DRUG), Truvada plus Leuprolide 11.25mg intramuscular injection (DRUG), Truvada plus Estradiol 1 mg (DRUG), Truvada plus Estradiol 6 mg (DRUG), Estradiol 6 mg alone (DRUG).
Who is sponsoring clinical trial NCT04760691?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04760691's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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