Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
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.
Hepatitis C Virus Infection
Herpesvirus 2, Human
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- The number of study participants who experience adverse events while receiving valacyclovir. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]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.
- The effect of valacyclovir compared with placebo to serum levels of HCV RNA [ Time Frame: 18 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|United States, Mississippi|
|G.V. Sonny Montgomery VA Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Mary Jane Burton, M.D.||G.V. (Sonny) Montgomery VA Medical Center|