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

Infection Clinical Trial

Official title:

The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01037621
• Other study ID #: VAL R 152
• Secondary ID: 2009-00348
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 22, 2009
• Last updated: November 4, 2011
• Start date: April 2010
• Est. completion date: February 2012

Study information

• Verified date: November 2011
• Source: G.V. (Sonny) Montgomery VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Herpes Simplex
• Herpesvirus 2, Human
• Infection
• Virus Diseases

Intervention

Drug:
• Valacyclovir
Valacyclovir 500 mg, 2 caplets twice daily for eight weeks

Locations

Country	Name	City	State
United States	G.V. Sonny Montgomery VA Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
G.V. (Sonny) Montgomery VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	18	No