Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

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:
NCT01453075
First received: October 7, 2011
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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 GV Sonny Montgomery VA Medical Center.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: Valacyclovir
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Effect of HSV-2 suppression on HCV viral load. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Measure the decline in serum HCV viral load in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo for 12 weeks.


Secondary Outcome Measures:
  • Effect of 3 grams daily valacyclovir on liver tests in hepatitis C infection [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    The investigators will assess the number of patients with chronic hepatitis C and HSV-2 co-infection who experience symptomatic and asymptomatic elevation liver function tests to valacyclovir 3 grams daily for 12 weeks.


Estimated Enrollment: 125
Study Start Date: November 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Assigned patients will take 1.5 mg po valacyclovir twice daily
Drug: Valacyclovir
Valacyclovir 1.5 mg po bid
Placebo Comparator: Arm 2
Assigned patients will receiving matching placebo twice daily
Drug: Placebo
Matching placebo twice daily

Detailed Description:

Study is a randomized, double-blinded, placebo-controlled, Phase II clinical trial. Participants will be recruited while attending regularly scheduled clinic appointments at the Jackson VAMC. Baseline Visit. Participants will be randomized 1:1 in groups of 10 to receive valacyclovir 1.5 gram orally twice daily or matching placebo. Enrolled participants will complete 12 weeks of assigned therapy.

At the initial visit, participants will complete a short questionnaire detailing past medical/social history and relevant symptoms. Venipuncture will be performed to obtain samples for the laboratory tests. The baseline de-identified serum sample will be obtained from the clinical lab and stored in research-approved freezer space for future confirmation with the Biokit HSV-2 rapid assay. Follow-up visits will be scheduled at two-week intervals after baseline. At each visit, pill-count, compliance and tolerability of medications will be assessed using a short questionnaire. Venipuncture will be performed every four weeks (i.e., at every other follow-up visit) to provide samples for the tests described below. Information from each study visit will be recorded into the chart by the PI or RA and entered into an encrypted database on a VA server. Laboratory Tests. HSV-2 infection will be confirmed by performing the Biokit HSV-2 rapid assay on the baseline stored serum sample using methods previously described in this proposal. Laboratory tests will include 1) complete blood count, comprehensive metabolic profile, and quantitative HCV RNA; and 2) Focus HerpeSelect HSV-1 IgG for participants who were seronegative for HSV-1 at baseline. Patient's IL28-B genotype will also be assessed at baseline. The PI will review all laboratory parameters.

Baseline characteristics between the groups will be compared using appropriate parametric tests. Analysis will be intention to treat with the inclusion of all subjects who were randomized to drug or placebo. The primary outcome is change in HCV viral load in the treatment group compared with placebo. Because we are expecting a 0.5 log10 decline in HCV viral load, we will use one-sided parametric tests. All viral loads will be log10-transformed before analysis. We anticipate using a higher cut-off will eliminate false positive HerpeSelect HSV-2 IgG assays.

  Eligibility

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

Inclusion Criteria:

  • Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay

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
  • Therapy for hepatitis C in the previous 6 months
  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: NCT01453075

Contacts
Contact: Mary J Burton, MD (601) 362-4471 ext 1842 mary.burton2@va.gov
Contact: Casey Young, MS (601) 362-4471

Locations
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS Recruiting
Jackson, Mississippi, United States, 39216
Contact: Mary J Burton, MD    601-362-4471 ext 1842    mary.burton2@va.gov   
Sub-Investigator: Casey Young, MS         
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: NCT01453075     History of Changes
Obsolete Identifiers: NCT01525342
Other Study ID Numbers: CLIN-001A-10F, 1lK2CX00536, VAL115610
Study First Received: October 7, 2011
Last Updated: June 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hepatitis C
herpes simplex type 2
veterans

Additional relevant MeSH terms:
Communicable Diseases
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
Acyclovir
Valacyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014