Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
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|ClinicalTrials.gov Identifier: NCT01037621|
Recruitment Status : Unknown
Verified November 2011 by Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center.
Recruitment status was: Active, not recruiting
First Posted : December 23, 2009
Last Update Posted : November 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection Infection Herpesvirus 2, Human||Drug: Valacyclovir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||February 2012|
- Drug: Valacyclovir
Valacyclovir 500 mg, 2 caplets twice daily for eight weeksOther Name: VALTREX
- The number of study participants who experience adverse events while receiving valacyclovir. [ Time Frame: 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.
- The effect of valacyclovir compared with placebo to serum levels of HCV RNA [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037621
|United States, Mississippi|
|G.V. Sonny Montgomery VA Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Mary Jane Burton, M.D.||G.V. (Sonny) Montgomery VA Medical Center|