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NCT01047540 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
A Phase 2 study of HSV-2, sponsored by AiCuris Anti-infective Cures.
- Completed
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
- 6
- Study locations
NCT01047540: Completed Phase 2 study of HSV-2, sponsored by AiCuris Anti-infective Cures.
NCT01047540 is a Phase 2 study of HSV-2 that has completed, run by AiCuris Anti-infective Cures. The registered enrollment target is 156 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01047540, a Phase 2 study of HSV-2, has completed, sponsored by AiCuris Anti-infective Cures.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
- 6
- Study locations
Study Summary
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
Primary Outcome
Subjects were assessed for shedding rate as the percentage of number of swab days with at least one swab positive for HSV DNA relative to the total number of days with analyzable swabs. Measurement was based on presence of HSV DNA measured on the material collected from swabs taken at the visits by the investigator and daily swabbing of the anogenital region by the patient during the treatment and post-treatment period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AIC316
Study Locations (6)
Florida
- Cetero Research Miami Gardens - Miami
Indiana
- Indiana University School of Medicine, Office for Research - Indianapolis
Oregon
- Westover Heights Clinic - Portland
Texas
- University of Texas Health Science Centre, Center for Clincial Studies - Houston
Utah
- University of Utah - Salt Lake City
Washington
- University of Washington, Virology Research Clinic - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT01047540 record still lists
NCT01047540 is an interventional study that assigns participants to a tested intervention. The registered 156 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 (17% higher).
The record links to 1 condition, with HSV-2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01047540 lists 6 locations in 6 states (Florida, Indiana, Oregon).
Frequently Asked Questions
What is clinical trial NCT01047540 about?
NCT01047540 is a clinical study titled "Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2". The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
What is the current status of trial NCT01047540?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2010-03. Estimated completion is 2011-03.
What conditions does trial NCT01047540 study?
This clinical trial studies the following conditions: HSV-2.
What interventions are being tested in trial NCT01047540?
The interventions under investigation include: Placebo (DRUG), AIC316 (DRUG).
Who is sponsoring clinical trial NCT01047540?
This trial is sponsored by AiCuris Anti-infective Cures, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01047540 being conducted?
This trial has 6 study locations across Florida, Indiana, Oregon, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01047540's enrollment target sits among peer trials
156 445th of 2000 higher than 1,553 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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