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NCT00158860 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 384
- Enrollment target
NCT00158860: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00158860 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 384 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00158860, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 384 participants
- Enrollment target
Study Summary
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.
Primary Outcome
Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.
Interventions
- DRUG Placebo
- DRUG Valaciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2004-06-21 |
| Est. Completion | 2006-07-26 |
| Phase | Phase 4 |
What the finished NCT00158860 record still lists
NCT00158860 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00158860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00158860 about?
NCT00158860 is a clinical study titled "A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.". Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests th...
What is the current status of trial NCT00158860?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 384 participants. The study started on 2004-06-21. Estimated completion is 2006-07-26.
What interventions are being tested in trial NCT00158860?
The interventions under investigation include: Placebo (DRUG), Valaciclovir (DRUG).
Who is sponsoring clinical trial NCT00158860?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00158860's enrollment target sits among peer trials
384 222nd of 2000 higher than 1,779 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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