Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

Study Overview
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Brief Summary
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This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.

Official Title
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The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load

Conditions
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Hepatitis C Virus Infection, Infection, Herpesvirus 2, Human

Intervention / Treatment
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* Drug: Valacyclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of hepatitis C infection Clinical diagnosis of herpes simplex type 2 infection Exclusion Criteria: HIV infection Other forms of chronic liver disease Chronic medical conditions On immunosuppressive medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valacyclovir|Valacyclovir 500 mg, 2 caplets twice daily for eight weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of study participants who experience adverse events while receiving valacyclovir. | Tolerability assessments will be performed very two weeks while on study medications. Complete blood cell count, creatinine clearance and liver function tests will be performed every four weeks while on medications. Adverse events will be graded using the Division of AIDS Adverse Event Grading Table, Version 1.0, clarification August 2009. Based on previous clinical experience with valacyclovir, we expect the drug will be well-tolerated in patients with hepatitis C. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of valacyclovir compared with placebo to serum levels of HCV RNA | Serum HCV RNA will be measured at baseline and every four weeks while on study medication. We expect to see a decrease in HCV RNA >0.5 log10IU/mL during the valacyclovir phase compared with the placebo phase. The cross-over design will allow each patient to serve as their own control, providing data on the effect of HSV-2 suppression on HCV RNA. | 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes simplex type 2, Hepatitis C virus, Valacyclovir, Herpes Simplex virus type 2 infection