Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
3 other identifiers
interventional
31
1 country
1
Brief Summary
The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes. Some persons with genital herpes have sores in their private areas but most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly used to treat or prevent outbreaks of genital herpes. This medication is already approved by the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved to treat chronic hepatitis C. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the persons participating will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 3-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
November 22, 2016
CompletedNovember 22, 2016
September 1, 2016
3.7 years
October 7, 2011
June 13, 2016
September 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of HSV-2 Suppression on HCV Viral Load.
Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo
baseline; 12 weeks
Study Arms (2)
Arm 1: valacyclovir
EXPERIMENTALAssigned patients will take 1.5 mg po valacyclovir twice daily
Arm 2: placebo
PLACEBO COMPARATORAssigned patients will receiving matching placebo twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay
You may not qualify if:
- Antiherpes or immunomodulatory therapy during the past 30 days
- HIV or chronic hepatitis B infection
- Decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus)
- Creatinine clearance \< 50 ml/min.
- Female subject who is pregnant or nursing
- Gastrointestinal disorder which might result in malabsorption of valacyclovir
- History of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome
- Therapy for hepatitis C in the previous 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- GlaxoSmithKlinecollaborator
Study Sites (1)
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Jackson, Mississippi, 39216, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Jane Burton
- Organization
- VA ORD
Study Officials
- PRINCIPAL INVESTIGATOR
Mary J Burton, MD
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2011
First Posted
October 17, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
November 22, 2016
Results First Posted
November 22, 2016
Record last verified: 2016-09