Chronic Hepatitis C InfectionPhase 1NCT01453075
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
A Phase 1 study testing Valacyclovir in people with Chronic Hepatitis C Infection, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- Valacyclovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Jackson, Mississippi, 39216
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- Valacyclovir, Placebo
- Keywords
- hepatitis C, herpes simplex type 2, veterans
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
Valacyclovir 1.5 mg po bid
PlaceboDrug
Matching placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: valacyclovir | Experimental | Assigned patients will take 1.5 mg po valacyclovir twice daily Receives: Drug: Valacyclovir |
| Arm 2: placebo | Placebo comparator | Assigned patients will receiving matching placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of HSV-2 Suppression on HCV Viral Load.
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
Measured: baseline; 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Mary J Burton, MD, Principal investigator, G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453075
- Sponsor's protocol ID
- CLIN-001A-10F
- Other IDs
- 1lK2CX00536, VAL115610
- Status last verified
- Sep 2016
- First submitted
- 7 Oct 2011
- Last updated
- 22 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and Herpes Simplex Virus 2 (HSV-2) Infection (Phase I)
- ClinicalTrials.gov ID
- NCT01453075
- Acronym / sponsor ID
- CLIN-001A-10F
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- hepatitis C, herpes simplex type 2, veterans
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Posted 22 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: valacyclovir | Experimental | Drug: ValacyclovirAssigned patients will take 1.5 mg po valacyclovir twice daily |
| Arm 2: placebo | Placebo comparator | Drug: PlaceboAssigned patients will receiving matching placebo twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValacyclovirValacyclovir 1.5 mg po bid | Drug | Arm 1: valacyclovir |
| PlaceboMatching placebo twice daily | Drug | Arm 2: placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Hepatitis C Infection
RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
Hepatitis B, Chronic
Active, not recruitingPhase 2/3
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
Chronic Hepatitis D Infection
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Active, not recruitingPhase 1
A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
Chronic Hepatitis B Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary J Burton, MD principal investigator
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valacyclovir in people with Chronic Hepatitis C Infection, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of HSV-2 Suppression on HCV Viral Load. (time frame: baseline; 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.