Phase 1 N=31 Randomized Quadruple-blind Treatment

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

Chronic Hepatitis C Infection

Bottom Line

View on ClinicalTrials.gov: NCT01453075 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: Effect of HSV-2 Suppression on HCV Viral Load. — .18; .03 log(IU/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Valacyclovir (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of HSV-2 Suppression on HCV Viral Load.	.18; .03	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01453075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.