CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Valacyclovir +1 moredrug
Likely dose
Valacyclovir 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01580995
NCT01580995Phase 2Completed

HSV-1 Suppression in HCV Infected Veterans Who Are Seronegative for HSV-2

VA Office of Research and Development·interventional·Posted Apr 19, 2012·Updated Sep 21, 2016

In Brief

A Phase 2 clinical trial evaluating Valacyclovir and Placebo for Chronic Hepatitis C Infection. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, also known as herpes labialis, but most persons do not have any symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic hepatitis C infection. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and patients will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.2 years ago

Interventions

Valacyclovirdrug

Valacyclovir 500 mg po bid

Placebodrug

Placebo tablet twice daily