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

Phase 1

• Conditions: Infection; Hepatitis C Virus Infection; Herpesvirus 2, Human

• Registration Number: NCT01037621
• Lead Sponsor: G.V. (Sonny) Montgomery VA Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Study Start: 2010-04
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-06
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The number of study participants who experience adverse events while receiving valacyclovir.	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 Outcome Measures

Name	Time	Method
The effect of valacyclovir compared with placebo to serum levels of HCV RNA	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.

Trial Locations

Locations (1)

G.V. Sonny Montgomery VA Medical Center; 🇺🇸 Jackson, Mississippi, United States