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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center
ClinicalTrials.gov Identifier:
NCT01037621
First received: December 22, 2009
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C Virus Infection
Infection
Herpesvirus 2, Human
 Drug: Valacyclovir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by G.V. (Sonny) Montgomery VA Medical Center:

Primary Outcome Measures:
  • The number of study participants who experience adverse events while receiving valacyclovir. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The effect of valacyclovir compared with placebo to serum levels of HCV RNA [ Time Frame: 18 ] [ Designated as safety issue: No ]
    Serum HCV RNA will be measured at baseline and every four weeks while on study medication. We expect to see a decrease in HCV RNA >0.5 log10IU/mL during the valacyclovir phase compared with the placebo phase. The cross-over design will allow each patient to serve as their own control, providing data on the effect of HSV-2 suppression on HCV RNA.


Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Valacyclovir
    Valacyclovir 500 mg, 2 caplets twice daily for eight weeks
    Other Name: VALTREX
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037621

Locations
United States, Mississippi
G.V. Sonny Montgomery VA Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
G.V. (Sonny) Montgomery VA Medical Center
Investigators
Principal Investigator: Mary Jane Burton, M.D. G.V. (Sonny) Montgomery VA Medical Center
  More Information

No publications provided

Responsible Party: Wanda Hayes, Administrative Officer, Research and Development, G.V. (Sonny) Montgomery VA Medical Center
ClinicalTrials.gov Identifier: NCT01037621     History of Changes
Other Study ID Numbers: VAL R 152, 2009-00348
Study First Received: December 22, 2009
Last Updated: November 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by G.V. (Sonny) Montgomery VA Medical Center:
Herpes simplex type 2
Hepatitis C virus
Valacyclovir
Herpes Simplex virus type 2 infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Herpes Simplex
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013