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Herpes Simplex Type 1 Suppression in Hepatitis C

NCT01580995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-09-21

Study results available
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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.

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

Valacyclovir

Valacyclovir 500 mg po bid

DRUG

Placebo

Placebo tablet twice daily

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Mary J Burton, MD · G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01580995 on ClinicalTrials.gov