Trial · NCT00158860
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.
NCT00158860, Phase 4, Completed, GlaxoSmithKline; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT00158860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00158860
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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.
- NCT number
- NCT00158860
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 384 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Herpes Genitalis
- Interventions
- Valaciclovir, Placebo
- First posted
- 2005-09-12
- Last updated
- 2019-02-15
- Results first posted
- 2019-02-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Time to First GH Recurrence | Day 168 | 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. |
| Secondary | Mean Number of GH Recurrences Per Month Within the 6-month Study Period | Up to Day 168 | Mean number of GH recurrence reaching macular/papular stage per month was reported. Diary cards were issued to the participants during randomization visit for the recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Upto Day 168 | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose results in death, was life-threatening, required hospitalization or prolongation of hospitalization, results in disability/incapacity, was a congenital anomaly/birth defect or medically significant. |
| Secondary | Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months | Day 168 | Diary cards were issued to the participants during randomization visit for recording HSV outbreak within 6-momths. HSV outbreak was assessed after review of the diary card and discussion with the participant. The percentage of participants who had first oral HSV outbreak at 6-months was reported. |
| Secondary | Number of Isolates With Resistance to Acyclovir (ACV) | Day 168 | Culture samples were tested for AVC-susceptibility by the analytical laboratory. Re-testing of the ACV resistant isolates was carried out to check if the half maximal inhibitory concentration (IC-50s) for all the ACV resistant isolates were within the expected errors of 2.0 microgram per milliliters (mcg/ml) cut-off for the plaque reduction assay. Those isolates that confirm to be resistant in repeat assays were considered as resistant to ACV. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Time to First GH Recurrence | Day 168 | ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product. | Percentage of participants | NUMBER |
| SECONDARY | Mean Number of GH Recurrences Per Month Within the 6-month Study Period | Up to Day 168 | ITT population. Only those participants available at the specified time points were analyzed. | Number of recurrences | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Upto Day 168 | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months | Day 168 | ITT population | Percentage of participants | NUMBER |
| SECONDARY | Number of Isolates With Resistance to Acyclovir (ACV) | Day 168 | ITT population. | Number of isolates | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Time to First GH Recurrence | Placebo | 43 | Percentage of participants | ||
| Percentage of Participants With Time to First GH Recurrence | Valaciclovir 1g QD | 71 | Percentage of participants | ||
| Mean Number of GH Recurrences Per Month Within the 6-month Study Period | Placebo | 0.48 | Standard Deviation 1.860 | Number of recurrences | |
| Mean Number of GH Recurrences Per Month Within the 6-month Study Period | Valaciclovir 1g QD | 0.11 | Standard Deviation 0.254 | Number of recurrences | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Any AEs | 98 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Valaciclovir 1g QD | Any AEs | 185 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Any SAEs | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Valaciclovir 1g QD | Any SAEs | 3 | Participants | |
| Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months | Placebo | 11 | Percentage of participants | ||
| Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months | Valaciclovir 1g QD | 14 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 128 | |
| Overall Study | STARTED | Valaciclovir 1g QD | 255 | |
| Overall Study | COMPLETED | Placebo | 93 | |
| Overall Study | COMPLETED | Valaciclovir 1g QD | 184 | |
| Overall Study | NOT COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Valaciclovir 1g QD | 71 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 13 | 128 | |
| other | Nasopharyngitis | Infections and infestations | Valaciclovir 1g QD | 35 | 255 | |
| other | Herpes simplex | Infections and infestations | Placebo | 8 | 128 | |
| other | Herpes simplex | Infections and infestations | Valaciclovir 1g QD | 22 | 255 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Placebo | 12 | 128 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Valaciclovir 1g QD | 16 | 255 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 9 | 128 | |
| other | Urinary tract infection | Infections and infestations | Valaciclovir 1g QD | 7 | 255 | |
| other | Influenza | Infections and infestations | Placebo | 7 | 128 | |
| other | Influenza | Infections and infestations | Valaciclovir 1g QD | 7 | 255 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 128 |
| Total, all-cause mortality | Valaciclovir 1g QD | 1 | 255 |
| Total, other adverse events | Placebo | 75 | 128 |
| Total, other adverse events | Valaciclovir 1g QD | 138 | 255 |
| Total, serious adverse events | Placebo | 4 | 128 |
| Total, serious adverse events | Valaciclovir 1g QD | 3 | 255 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Valaciclovir 1g QD vs Placebo: deaths from any cause | Trial comparisons |
| Valaciclovir 1g QD vs Placebo: serious adverse events | 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/NCT00158860
GET https://conductscience.org/api/trials/v1/NCT00158860/events?page=2