Trial · NCT00362297
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
NCT00362297, Phase 4, Completed, University of Washington; results first posted 2014-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2. Trials, record NCT00362297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00362297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
- NCT number
- NCT00362297
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 31 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Genital Herpes
- Interventions
- acyclovir, valacyclovir
- First posted
- 2006-08-09
- Last updated
- 2021-11-18
- Results first posted
- 2014-10-08
- Limitations and caveats
The trial was performed at a single site, and enrolled mostly white, healthy, sexually active adults with high rates of genital HSV-2 recurrence. The results may not be generalizable to other populations.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. | 15 weeks | Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression. Shedding rates were calculated by dividing the number of positive swabs by the total number of swabs for each intervention group. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. | 15 weeks | Participants who did not collect at least one swab on each arm of the cross-over were excluded from analysis. | percentage of swabs with HSV detected | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. | Standard Dose Valacyclovir | 4 | percentage of swabs with HSV detected | ||
Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. | High Dose Acyclovir | 4 | percentage of swabs with HSV detected |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment 1 (Initial Drug Assignment) | STARTED | Standard Dose First, Then High Dose | 16 | |
| Treatment 1 (Initial Drug Assignment) | STARTED | High Dose First, Then Standard Dose | 15 | |
| Treatment 1 (Initial Drug Assignment) | COMPLETED | Standard Dose First, Then High Dose | 16 | |
| Treatment 1 (Initial Drug Assignment) | COMPLETED | High Dose First, Then Standard Dose | 11 | |
| Treatment 1 (Initial Drug Assignment) | NOT COMPLETED | Standard Dose First, Then High Dose | 0 | |
| Treatment 1 (Initial Drug Assignment) | NOT COMPLETED | High Dose First, Then Standard Dose | 4 | |
| Treatment 2 | STARTED | Standard Dose First, Then High Dose | 16 | |
| Treatment 2 | STARTED | High Dose First, Then Standard Dose | 11 | |
| Treatment 2 | COMPLETED | Standard Dose First, Then High Dose | 16 | |
| Treatment 2 | COMPLETED | High Dose First, Then Standard Dose | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Dose | ||
| Total, all-cause mortality | High-dose | ||
| Total, other adverse events | Standard Dose | 0 | 27 |
| Total, other adverse events | High-dose | 0 | 31 |
| Total, serious adverse events | Standard Dose | 0 | 27 |
| Total, serious adverse events | High-dose | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22225814 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Standard Dose vs High-dose: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00362297
GET https://conductscience.org/api/trials/v1/NCT00362297/registered