Trial · NCT01453075
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
NCT01453075, Phase 1, Completed, VA Office of Research and Development; results first posted 2016-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I). Trials, record NCT01453075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01453075
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
- NCT number
- NCT01453075
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Chronic Hepatitis C Infection
- Interventions
- Valacyclovir, Placebo
- First posted
- 2011-10-17
- Last updated
- 2016-11-22
- Results first posted
- 2016-11-22
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of HSV-2 Suppression on HCV Viral Load. | baseline; 12 weeks | Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo |
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 | Effect of HSV-2 Suppression on HCV Viral Load. | baseline; 12 weeks | Analyzed patients who completed study | log(IU/mL) | MEAN |
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 |
|---|---|---|---|---|---|
| Effect of HSV-2 Suppression on HCV Viral Load. | Arm 1: Valacyclovir | .18 | Standard Error .104 | log(IU/mL) | |
| Effect of HSV-2 Suppression on HCV Viral Load. | Arm 2: Placebo | .03 | Standard Error .75 | log(IU/mL) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Valacyclovir | 16 | |
| Overall Study | STARTED | Arm 2: Placebo | 15 | |
| Overall Study | COMPLETED | Arm 1: Valacyclovir | 11 | |
| Overall Study | COMPLETED | Arm 2: Placebo | 14 | |
| Overall Study | NOT COMPLETED | Arm 1: Valacyclovir | 5 | |
| Overall Study | NOT COMPLETED | Arm 2: Placebo | 1 |
Source ClinicalTrials.gov
Adverse 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 | Arm 1: Valacyclovir | ||
| Total, all-cause mortality | Arm 2: Placebo | ||
| Total, other adverse events | Arm 1: Valacyclovir | 0 | 16 |
| Total, other adverse events | Arm 2: Placebo | 0 | 15 |
| Total, serious adverse events | Arm 1: Valacyclovir | 0 | 16 |
| Total, serious adverse events | Arm 2: Placebo | 0 | 15 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1: Valacyclovir vs Arm 2: Placebo: 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/NCT01453075
GET https://conductscience.org/api/trials/v1/NCT01453075/registered