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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: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT01772823 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal.
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 |
What the finished NCT01772823 record still lists
NCT01772823 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 3 interventions - of which PCC is the first listed.
NCT01772823 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01772823's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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