Status:
COMPLETED
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
Study is a randomized, double-blinded, placebo-controlled, Phase II clinical trial. Participants will be recruited while attending regularly scheduled clinic appointments at the Jackson VA Medical Cen...
Eligibility Criteria
Inclusion
- Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01453075
Start Date
November 1 2011
End Date
December 1 2015
Last Update
November 22 2016
Active Locations (1)
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1
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Jackson, Mississippi, United States, 39216