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

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Hepatitis C Infection

In brief

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.

Key facts

Study ID

NCT01453075

Run by

VA Office of Research and Development

People needed

31

Starts

2011-11-01

Expected to finish

2015-12-01

Last updated by the study team

2016-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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