Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by G.V. (Sonny) Montgomery VA Medical Center.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center Identifier:
First received: December 22, 2009
Last updated: November 4, 2011
Last verified: November 2011

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
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:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01037621

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
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 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
Herpes Simplex virus type 2 infection

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015