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NCT00362297 · ClinicalTrials.gov registry record · Phase 4
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT00362297 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 31 participants.
The verdict
NCT00362297, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic genital shedding in persons with genital herpes. The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control. Involvement in the study will last 15-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or acyclovir; you will receive both medications at some point during this study). There will be a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.
Interventions
- DRUG valacyclovir
- DRUG acyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-09 |
| Est. Completion | 2011-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00362297
The ClinicalTrials.gov registry entry for NCT00362297 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which valacyclovir is the first listed.
NCT00362297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00362297 about?
NCT00362297 is a clinical study titled "Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2". The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic genital shedding in persons with genital herpes. The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and...
What is the current status of trial NCT00362297?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2006-09. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00362297?
The interventions under investigation include: valacyclovir (DRUG), acyclovir (DRUG).
Who is sponsoring clinical trial NCT00362297?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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