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NCT01772823 · ClinicalTrials.gov registry record · Phase 2
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT01772823 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 200 participants.
The verdict
NCT01772823, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.
Interventions
- BEHAVIORAL PCC
- DRUG Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- BEHAVIORAL 3MV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01772823
The ClinicalTrials.gov registry entry for NCT01772823 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which PCC is the first listed.
NCT01772823 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01772823 about?
NCT01772823 is a clinical study titled "An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis". Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, whi...
What is the current status of trial NCT01772823?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2012-11. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01772823?
The interventions under investigation include: PCC (BEHAVIORAL), Emtricitabine/tenofovir (FTC/TDF (Truvada®)) (DRUG), 3MV (BEHAVIORAL).
Who is sponsoring clinical trial NCT01772823?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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