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

NCT01037621 | Unknown Phase 1

• 2 other identifiers: VAL R 1522009-00348
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C Virus Infection; Infection; Herpesvirus 2, Human

Keywords

Herpes simplex type 2; Hepatitis C virus; Valacyclovir; Herpes Simplex virus type 2 infection

Outcome Measures

Primary Outcomes (1)

• The number of study participants who experience adverse events while receiving valacyclovir.

  Tolerability assessments will be performed very two weeks while on study medications. Complete blood cell count, creatinine clearance and liver function tests will be performed every four weeks while on medications. Adverse events will be graded using the Division of AIDS Adverse Event Grading Table, Version 1.0, clarification August 2009. Based on previous clinical experience with valacyclovir, we expect the drug will be well-tolerated in patients with hepatitis C.

  18 weeks

Secondary Outcomes (1)

• The effect of valacyclovir compared with placebo to serum levels of HCV RNA

  18

Interventions

Valacyclovir DRUG

Valacyclovir 500 mg, 2 caplets twice daily for eight weeks

Also known as: VALTREX

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• G.V. (Sonny) Montgomery VA Medical Center: lead

Study Sites (1)

G.V. Sonny Montgomery VA Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Hepatitis C; Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mary Jane Burton, M.D.

  G.V. (Sonny) Montgomery VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrative Officer, Research and Development

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 7, 2011

Record last verified: 2011-11

Locations

US (1)