Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | December 2015 |
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and Herpes Simplex Virus 2 (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 G.V. Sonny Montgomery VA Medical Center.
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.
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.
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.
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
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