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

G.V. (Sonny) Montgomery VA Medical Center

Status and phase: Unknown; Phase 1

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

Treatments: Drug: Valacyclovir

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01037621

VAL R 152

2009-00348 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind