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NCT04616963 · ClinicalTrials.gov registry record · Phase 4
Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis
A Phase 4 study of HIV and Hormone Therapy, sponsored by University of California, San Diego.
- Active
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04616963 is a Phase 4 study of HIV and Hormone Therapy that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 64 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04616963, a Phase 4 study of HIV and Hormone Therapy, is active but no longer recruiting, sponsored by University of California, San Diego.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.
Conditions Studied
Interventions
- DRUG Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg
- DRUG Emtricitabine Tenofovir Alafenamide 200/25 mg
Study Locations (1)
California
- UC San Diego AntiViral Research Center (AVRC) - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-10-24 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04616963
The ClinicalTrials.gov registry entry for NCT04616963 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (85% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg is the first listed.
NCT04616963 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04616963 about?
NCT04616963 is a clinical study titled "Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis". The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily...
What is the current status of trial NCT04616963?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2019-10-24. Estimated completion is 2024-01-31.
What conditions does trial NCT04616963 study?
This clinical trial studies the following conditions: HIV, Hormone Therapy.
What interventions are being tested in trial NCT04616963?
The interventions under investigation include: Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg (DRUG), Emtricitabine Tenofovir Alafenamide 200/25 mg (DRUG).
Who is sponsoring clinical trial NCT04616963?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04616963 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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