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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04760691
The ClinicalTrials.gov registry entry for NCT04760691 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Truvada alone is the first listed.
NCT04760691 reports 0 study locations.
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.
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