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Trial record 61 of 126 for:    HSV-2

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

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: NCT01580995
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: Valacyclovir Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: HSV-1 Suppression in HCV Infected Veterans Who Are Seronegative for HSV-2
Study Start Date : April 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Valacyclovir
Valacyclovir 500 mg po bid
Drug: Valacyclovir
Valacyclovir 500 mg po bid

Placebo Comparator: Placebo
Matching placebo twice daily
Drug: Placebo
Placebo tablet twice daily

Primary Outcome Measures :
  1. 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

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:

  • 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.

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): NCT01580995

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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: NCT01580995     History of Changes
Other Study ID Numbers: CLIN-001C-10F
First Posted: April 19, 2012    Key Record Dates
Results First Posted: September 21, 2016
Last Update Posted: September 21, 2016
Last Verified: August 2016
Keywords provided by VA Office of Research and Development:
Chronic hepatitis C infection
Additional relevant MeSH terms:
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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