- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01580995
Herpes Simplex Type 1 Suppression in Hepatitis C (HSV1/HCV)
HSV-1 Suppression in HCV Infected Veterans Who Are Seronegative for HSV-2
The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, also known as herpes labialis, but most persons do not have any symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic hepatitis C infection.
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 patients will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized double-blind placebo-controlled clinical trial evaluating the effect of 500 mg valacyclovir twice daily on HCV viral load in HSV-1/HCV co-infected patients seronegative for HSV-2. Potential participants will be recruited from the Jackson VAMC viral hepatitis clinics. Eligible individuals will be invited to enroll in the study in a noncoercive manner. Study personnel will obtain full informed consent.
Using a computer generation randomization scheme, patients will be randomized 1:1 in blocks of 4 to receive valacyclovir 500 mg po twice daily or matching placebo. Patients will be counseled on the signs and symptoms of herpes labialis and genital herpes and complete a questionnaire to document medical/social history. Venipuncture will be performed every four weeks (i.e., at every other follow-up visit) to monitor complete blood cell count, liver function tests, serum levels of hepatitis C RNA and Herpeselect IgG HSV-2 ELISA. A de-identified baseline serum sample will be collected and stored in VA approved research space for future testing. At each visit, pill-count and tolerability of medications will be assessed. Patients will be asked about signs or symptoms of genital herpes. Data will be kept in a study chart labeled with the participant's coded study number in a locked office. Information from each study visit will be recorded into the chart by the PI or RA and entered into an encrypted database on a secure VA server. Baseline characteristics of the placebo and intervention group will be compared using appropriate parametric tests. HCV viral loads will be log10 transformed and analyzed using an intention to treat model.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic hepatitis C infection with a detectable HCV RNA in the serum on two occasions, 6 months apart
- Focus HSV-2 IgG negative and Focus HSV-1 IgG positive, using manufacturer's cut-offs
Exclusion Criteria:
- 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,
- Allergy to valacyclovir or related drug.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Matching placebo twice daily
|
Placebo tablet twice daily
|
Experimental: Valacyclovir
Valacyclovir 500 mg po bid
|
Valacyclovir 500 mg po bid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HCV RNA Viral Load
Time Frame: Baseline, 12 weeks
|
Measure change in HCV RNA viral load in treatment group as compared with placebo
|
Baseline, 12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mary J Burton, MD, G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Valacyclovir
Other Study ID Numbers
- CLIN-001C-10F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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