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
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

December 22, 2009
November 4, 2011
April 2010
February 2012   (final data collection date for primary outcome measure)
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.
The safety and tolerability of valacyclovir in veterans with hepatitis C and HSV-2 coinfection [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01037621 on ClinicalTrials.gov Archive Site
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.
The effect of valacyclovir compared with placebo to serum levels of HCV RNA [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hepatitis C Virus Infection
  • Infection
  • Herpesvirus 2, Human
Drug: Valacyclovir
Valacyclovir 500 mg, 2 caplets twice daily for eight weeks
Other Name: VALTREX
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01037621
VAL R 152, 2009-00348
No
Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center
G.V. (Sonny) Montgomery VA Medical Center
Not Provided
Principal Investigator: Mary Jane Burton, M.D. G.V. (Sonny) Montgomery VA Medical Center
G.V. (Sonny) Montgomery VA Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP