Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
This study is ongoing, but not recruiting participants.
Sponsor:
G.V. (Sonny) Montgomery VA Medical Center
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
| Tracking Information | |||||
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| First Received Date ICMJE | December 22, 2009 | ||||
| Last Updated Date | November 4, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
The safety and tolerability of valacyclovir in veterans with hepatitis C and HSV-2 coinfection [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01037621 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
The effect of valacyclovir compared with placebo to serum levels of HCV RNA [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C | ||||
| Official Title ICMJE | The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Valacyclovir
Valacyclovir 500 mg, 2 caplets twice daily for eight weeks
Other Name: VALTREX |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | February 2012 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01037621 | ||||
| Other Study ID Numbers ICMJE | VAL R 152, 2009-00348 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center | ||||
| Study Sponsor ICMJE | G.V. (Sonny) Montgomery VA Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | G.V. (Sonny) Montgomery VA Medical Center | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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