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Herpes Simplex Type 1 Suppression in Hepatitis C (HSV1/HCV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01580995
First received: April 13, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: Valacyclovir
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: HSV-1 Suppression in HCV Infected Veterans Who Are Seronegative for HSV-2

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in HCV RNA viral load [ Time Frame: Baseline, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Measure change in HCV RNA viral load in treatment group as compared with placebo


Estimated Enrollment: 25
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Valacyclovir 500 mg po bid
Drug: Valacyclovir
Valacyclovir 500 mg po bid
Placebo Comparator: 2
Matching placebo twice daily
Drug: Placebo
Placebo tablet twice daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580995

Contacts
Contact: Angela M Jones, RPh (601) 362-1315 angela.jones@va.gov
Contact: Jefferson D Parker, PhD BS (601) 364-4440 Jefferson.Parker@va.gov

Locations
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS Recruiting
Jackson, Mississippi, United States, 39216
Contact: Wanda Hayes    601-364-1315    wanda.hayes1@va.gov   
Principal Investigator: Mary J Burton, MD         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Principal Investigator: Mary J Burton, MD G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01580995     History of Changes
Other Study ID Numbers: CLIN-001C-10F
Study First Received: April 13, 2012
Last Updated: June 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Chronic hepatitis C infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Valacyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014