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

Conditions

• Chronic Hepatitis C Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Valacyclovir — DRUG
  Valacyclovir 1.5 mg po bid
• Placebo — DRUG
  Matching placebo twice daily

Study Details

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 Dates

Start date

Nov 30, 2011

Status verified

Sep 2016

Primary completion

Jul 31, 2015

Completion

Dec 31, 2015

Study Design

Enrollment

31 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: valacyclovir
  Assigned patients will take 1.5 mg po valacyclovir twice daily
• Placebo Comparator: Arm 2: placebo
  Assigned patients will receiving matching placebo twice daily

Primary Outcome Measure

Effect of HSV-2 Suppression on HCV Viral Load. [ Time Frame: baseline; 12 weeks ]

Locations (1)

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