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NCT01209325 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
A Phase 2 study, sponsored by AIDS Malignancy Consortium.
- Completed
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
NCT01209325: Completed Phase 2 study, sponsored by AIDS Malignancy Consortium.
NCT01209325 is a Phase 2 study that has completed, run by AIDS Malignancy Consortium. The registered enrollment target is 149 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01209325, a Phase 2 study, has completed, sponsored by AIDS Malignancy Consortium.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection. PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.
Primary Outcome
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2011-06-28 |
| Est. Completion | 2017-12-12 |
| Phase | Phase 2 |
What the finished NCT01209325 record still lists
NCT01209325 is an interventional study that assigns participants to a tested intervention. The registered 149 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 (12% higher).
The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT01209325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01209325 about?
NCT01209325 is a clinical study titled "Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males". RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection. PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who hav...
What is the current status of trial NCT01209325?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2011-06-28. Estimated completion is 2017-12-12.
What interventions are being tested in trial NCT01209325?
The interventions under investigation include: laboratory biomarker analysis (OTHER), quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01209325?
This trial is sponsored by AIDS Malignancy Consortium, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01209325's enrollment target sits among peer trials
149 491st of 2000 higher than 1,510 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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