Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
This trial is active, not recruiting.
|Conditions||hepatitis c virus infection, infection, herpesvirus 2, human|
|Sponsor||G.V. (Sonny) Montgomery VA Medical Center|
|Start date||April 2010|
|End date||February 2012|
|Trial size||50 participants|
|Trial identifier||NCT01037621, 2009-00348, VAL R 152|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator)|
The number of study participants who experience adverse events while receiving valacyclovir.
time frame: 18 weeks
The effect of valacyclovir compared with placebo to serum levels of HCV RNA
time frame: 18
Male or female participants at least 18 years old.
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
|Official title||The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load|
|Principal investigator||Mary Jane Burton, M.D.|
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