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NCT01769456 · ClinicalTrials.gov registry record · Phase 2
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT01769456: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT01769456 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769456, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all participating sites, Personalized Cognitive Counseling (PCC), and will then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as pre-exposure prophylaxis (PrEP). Behavioral and biomedical data will be collected at baseline and at 0, 4, 8, 12, 24, 36 and 48 weeks. Any subject who becomes HIV infected during the course of the study will be discontinued from the study agent and be 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 represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM. Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).
Interventions
- BEHAVIORAL PCC
- DRUG Emtricitabine/tenofovir (FTC/TDF (Truvada®))
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT01769456 record still lists
NCT01769456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which PCC is the first listed.
NCT01769456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01769456 about?
NCT01769456 is a clinical study titled "An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)". Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all participating sites, Personaliz...
What is the current status of trial NCT01769456?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2013-03. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01769456?
The interventions under investigation include: PCC (BEHAVIORAL), Emtricitabine/tenofovir (FTC/TDF (Truvada®)) (DRUG).
Who is sponsoring clinical trial NCT01769456?
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 NCT01769456's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 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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