Herpes Simplex Type 1 Suppression in Hepatitis C

Conditions

• Chronic Hepatitis C Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Valacyclovir — DRUG
  Valacyclovir 500 mg po bid
• Placebo — DRUG
  Placebo tablet twice daily

Study Details

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.

Key Dates

Start date

Apr 30, 2012

Status verified

Aug 2016

Primary completion

Dec 31, 2014

Completion

Mar 31, 2015

Study Design

Enrollment

19 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Valacyclovir
  Valacyclovir 500 mg po bid
• Placebo Comparator: Placebo
  Matching placebo twice daily

Primary Outcome Measure

Change in HCV RNA Viral Load [ Time Frame: Baseline, 12 weeks ]

Locations (1)

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