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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037621
First Posted: December 23, 2009
Last Update Posted: November 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Wanda Hayes, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: G. V. Sonny Montgomery VAMC IRB )
First Submitted: December 22, 2009
First Posted: December 23, 2009
Last Update Posted: November 7, 2011
Last Verified: November 2011

Keywords provided by Wanda Hayes, 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:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Herpes Simplex
Coinfection
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
Parasitic Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents