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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2012

Interventions

  • Drug: Valacyclovir
    • Valacyclovir 500 mg, 2 caplets twice daily for eight weeks

Clinical Trial Outcome Measures

Primary Measures

  • The number of study participants who experience adverse events while receiving valacyclovir.
    • Time Frame: 18 weeks
    • 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.

Secondary Measures

  • The effect of valacyclovir compared with placebo to serum levels of HCV RNA
    • Time Frame: 18
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • G.V. (Sonny) Montgomery VA Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wanda Hayes, Administrative Officer, Research and Development – G.V. (Sonny) Montgomery VA Medical Center
  • Overall Official(s)
    • Mary Jane Burton, M.D., Principal Investigator, G.V. (Sonny) Montgomery VA Medical Center

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