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Trial record 6 of 126 for:    HSV-2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01453075
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: Valacyclovir Drug: Placebo Phase 1

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 VA Medical Center. 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 Research Assistant (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 hepatitis C virus (HCV) RNA; and 2) Focus HerpeSelect HSV-1 Immunoglobulin G (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 the investigators are expecting a 0.5 log10 decline in HCV viral load, the investigators will use one-sided parametric tests. All viral loads will be log10-transformed before analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and Herpes Simplex Virus 2 (HSV-2) Infection (Phase I)
Study Start Date : November 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1: valacyclovir
Assigned patients will take 1.5 mg po valacyclovir twice daily
Drug: Valacyclovir
Valacyclovir 1.5 mg po bid

Placebo Comparator: Arm 2: placebo
Assigned patients will receiving matching placebo twice daily
Drug: Placebo
Matching placebo twice daily

Primary Outcome Measures :
  1. Effect of HSV-2 Suppression on HCV Viral Load. [ Time Frame: baseline; 12 weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01453075

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United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Mary J Burton, MD G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

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Responsible Party: VA Office of Research and Development Identifier: NCT01453075     History of Changes
Obsolete Identifiers: NCT01525342
Other Study ID Numbers: CLIN-001A-10F
1lK2CX00536 ( Other Identifier: VA CSR&D )
VAL115610 ( Other Identifier: VS CSR&D )
First Posted: October 17, 2011    Key Record Dates
Results First Posted: November 22, 2016
Last Update Posted: November 22, 2016
Last Verified: September 2016
Keywords provided by VA Office of Research and Development:
hepatitis C
herpes simplex type 2
Additional relevant MeSH terms:
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Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents