Back to resultsHerpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
Primary Purpose
Hepatitis C Virus Infection, Infection, Herpesvirus 2, Human
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Valacyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring Herpes simplex type 2, Hepatitis C virus, Valacyclovir, Herpes Simplex virus type 2 infection
Eligibility 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
Sites / Locations
- G.V. Sonny Montgomery VA Medical Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The effect of valacyclovir compared with placebo to serum levels of HCV RNA
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.
Full Information
NCT ID
NCT01037621
First Posted
December 22, 2009
Last Updated
November 4, 2011
Sponsor
G.V. (Sonny) Montgomery VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01037621
Brief Title
Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
Official Title
The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G.V. (Sonny) Montgomery VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection, Infection, Herpesvirus 2, Human
Keywords
Herpes simplex type 2, Hepatitis C virus, Valacyclovir, Herpes Simplex virus type 2 infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Other Intervention Name(s)
VALTREX
Intervention Description
Valacyclovir 500 mg, 2 caplets twice daily for eight weeks
Primary Outcome Measure Information:
Title
The number of study participants who experience adverse events while receiving valacyclovir.
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
The effect of valacyclovir compared with placebo to serum levels of HCV RNA
Description
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.
Time Frame
18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jane Burton, M.D.
Organizational Affiliation
G.V. (Sonny) Montgomery VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
G.V. Sonny Montgomery VA Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
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