Overview

This trial is active, not recruiting.

Conditions hepatitis c virus infection, infection, herpesvirus 2, human
Treatment valacyclovir
Phase phase 1
Sponsor G.V. (Sonny) Montgomery VA Medical Center
Start date April 2010
End date February 2012
Trial size 50 participants
Trial identifier NCT01037621, 2009-00348, VAL R 152

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment

Primary Outcomes

Measure
The number of study participants who experience adverse events while receiving valacyclovir.
time frame: 18 weeks

Secondary Outcomes

Measure
The effect of valacyclovir compared with placebo to serum levels of HCV RNA
time frame: 18

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load
Principal investigator Mary Jane Burton, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by G.V. (Sonny) Montgomery VA Medical Center.