Herpes Simplex Type 1 Suppression in Hepatitis C

NCT01580995 | Completed Phase 2 Results

• 1 other identifier: CLIN-001C-10F
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic hepatitis C infection

Outcome Measures

Primary Outcomes (1)

• Change in HCV RNA Viral Load

  Measure change in HCV RNA viral load in treatment group as compared with placebo

  Baseline, 12 weeks

Study Arms (2)

Valacyclovir

EXPERIMENTAL

Valacyclovir 500 mg po bid

Drug: Valacyclovir

Placebo

PLACEBO COMPARATOR

Matching placebo twice daily

Drug: Placebo

Interventions

Valacyclovir DRUG

Valacyclovir 500 mg po bid

Valacyclovir

Placebo DRUG

Placebo tablet twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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,
• Allergy to valacyclovir or related drug.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Interventions

Valacyclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mary Jane Burton
• Organization: VAORD

mary.burton2@va.gov

6013624471

Study Officials

• Mary J Burton, MD

  G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 19, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: September 21, 2016
• Results First Posted: September 21, 2016

Record last verified: 2016-08

Locations

US (1)