Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes. Some persons with genital herpes have sores in their private areas but most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly used to treat or prevent outbreaks of genital herpes. This medication is already approved by the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved to treat chronic hepatitis C.

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 the persons participating will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 3-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay

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

• Therapy for hepatitis C in the previous 6 months