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NCT01658826 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
A Phase 2 study, sponsored by AiCuris Anti-infective Cures.
- Terminated
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT01658826: Clinical Trial Phase 2 study, sponsored by AiCuris Anti-infective Cures.
NCT01658826 is a Phase 2 study that was terminated before completion, run by AiCuris Anti-infective Cures. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01658826, a Phase 2 study, was terminated before completion, sponsored by AiCuris Anti-infective Cures.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
Primary Outcome
Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point
Interventions
- DRUG Valacyclovir
- DRUG AIC316
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
Why NCT01658826 stopped before completion
NCT01658826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Valacyclovir is the first listed.
NCT01658826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01658826 about?
NCT01658826 is a clinical study titled "Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes". The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
What is the current status of trial NCT01658826?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2012-10. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01658826?
The interventions under investigation include: Valacyclovir (DRUG), AIC316 (DRUG).
Who is sponsoring clinical trial NCT01658826?
This trial is sponsored by AiCuris Anti-infective Cures, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01658826's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 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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