Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
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.
|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)|
- 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.
- 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.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Assigned patients will take 1.5 mg po valacyclovir twice daily
Valacyclovir 1.5 mg po bid
Placebo Comparator: Arm 2
Assigned patients will receiving matching placebo twice daily
Matching placebo twice daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453075
|Contact: Mary J Burton, MD||(601) 362-4471 ext firstname.lastname@example.org|
|Contact: Casey Young, MS||(601) 362-4471|
|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 email@example.com|
|Sub-Investigator: Casey Young, MS|
|Principal Investigator: Mary J Burton, MD|
|Principal Investigator:||Mary J Burton, MD||G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS|