Hepatitis C Virus Infection, Herpesvirus 2, Human, Infection
Conditions
Keywords
Herpes simplex type 2, Hepatitis C virus, Valacyclovir, Herpes Simplex virus type 2 infection
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.
Interventions
DRUGValacyclovir
Valacyclovir 500 mg, 2 caplets twice daily for eight weeks
Sponsors
G.V. (Sonny) Montgomery VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of study participants who experience adverse events while receiving valacyclovir. | 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
| Measure | Time frame | Description |
|---|---|---|
| The effect of valacyclovir compared with placebo to serum levels of HCV RNA | 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. |
Countries
United States
Outcome results
None listed