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

Information source: G.V. (Sonny) Montgomery VA Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Virus Infection; Infection; Herpesvirus 2, Human

Intervention: Valacyclovir (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: G.V. (Sonny) Montgomery VA Medical Center

Official(s) and/or principal investigator(s):
Mary Jane Burton, M.D., Principal Investigator, Affiliation: G.V. (Sonny) Montgomery VA Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The number of study participants who experience adverse events while receiving valacyclovir.

Secondary outcome: The effect of valacyclovir compared with placebo to serum levels of HCV RNA

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

G.V. Sonny Montgomery VA Medical Center, Jackson, Mississippi 39216, United States
Additional Information

Starting date: April 2010
Last updated: November 4, 2011

Page last updated: August 23, 2015

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