Chronic Hepatitis C InfectionPhase 2HSV1/HCVNCT01580995
Herpes Simplex Type 1 Suppression in Hepatitis C
A Phase 2 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 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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2015
- Phase
- Phase 2
- 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
- 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
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,
- Allergy to valacyclovir or related drug.
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: HSV-1 Suppression in HCV Infected Veterans Who Are Seronegative for HSV-2
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.
Read the 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.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- Valacyclovir, Placebo
- Keywords
- Chronic hepatitis C infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
Valacyclovir 500 mg po bid
PlaceboDrug
Placebo tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir | Experimental | Valacyclovir 500 mg po bid Receives: Drug: Valacyclovir |
| Placebo | Placebo comparator | Matching placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HCV RNA Viral Load
Measure change in HCV RNA viral load in treatment group as compared with 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 posted19 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionMar 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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
- NCT01580995
- Sponsor's protocol ID
- CLIN-001C-10F
- Acronym
- HSV1/HCV
- Status last verified
- Aug 2016
- First submitted
- 13 Apr 2012
- Last updated
- 21 Sep 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 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HSV-1 Suppression in HCV Infected Veterans Who Are Seronegative for HSV-2
- ClinicalTrials.gov ID
- NCT01580995
- Acronym / sponsor ID
- HSV1/HCV / CLIN-001C-10F
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- Chronic hepatitis C infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Posted 21 Sep 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir | Experimental | Drug: ValacyclovirValacyclovir 500 mg po bid |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
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 500 mg po bid | Drug | Valacyclovir |
| PlaceboPlacebo tablet twice daily | Drug | Placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2 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 2 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 21 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Sep 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?
Change in HCV RNA 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 21 Sep 2016.