Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-02-29

Brief Summary

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This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.

Detailed Description

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Conditions

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Hepatitis C Virus Infection Infection Herpesvirus 2, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Valacyclovir

Valacyclovir 500 mg, 2 caplets twice daily for eight weeks

Intervention Type DRUG

Other Intervention Names

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VALTREX

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of hepatitis C infection
* Clinical diagnosis of herpes simplex type 2 infection

Exclusion Criteria

* HIV infection
* Other forms of chronic liver disease
* Chronic medical conditions
* On immunosuppressive medications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Wanda Hayes

Administrative Officer, Research and Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Jane Burton, M.D.

Role: PRINCIPAL_INVESTIGATOR

G.V. (Sonny) Montgomery VA Medical Center

Locations

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G.V. Sonny Montgomery VA Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2009-00348

Identifier Type: OTHER

Identifier Source: secondary_id

VAL R 152

Identifier Type: -

Identifier Source: org_study_id