Herpes Simplex Type 1 Suppression in Hepatitis C

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, also known as herpes labialis, but most persons do not have any symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic hepatitis C infection.

The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and patients will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: GlaxoSmithKline
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

• Chronic hepatitis C infection with a detectable HCV RNA in the serum on two occasions, 6 months apart

• Focus HSV-2 IgG negative and Focus HSV-1 IgG positive, using manufacturer's cut-offs

Exclusion Criteria:

• Antiherpes or immunomodulatory therapy during the past 30 days,

• HIV or chronic hepatitis B infection,

• Decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus),

• Creatinine clearance <50 ml/min.,

• Female subject who is pregnant or nursing,

• Gastrointestinal disorder which might result in malabsorption of valacyclovir,

• History of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome,

• Allergy to valacyclovir or related drug.