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

Sponsor

G.V. (Sonny) Montgomery VA Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT01037621

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection Infection Herpesvirus 2, Human	Drug: Valacyclovir	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Feb 1, 2012

Anticipated Study Completion Date :

Feb 1, 2012

Outcome Measures

Primary Outcome Measures

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

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.