Hepatitis C Virus InfectionPhase 1NCT01037621
Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C
A Phase 1 study testing Valacyclovir in people with Hepatitis C Virus Infection and Infection, run by G.V. (Sonny) Montgomery VA Medical Center at 1 site in United States.
Trial summary
This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus Infection, Infection, Herpesvirus 2, Human
- What is being tested?
- Valacyclovir
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of hepatitis C infection
- Clinical diagnosis of herpes simplex type 2 infection
Who cannot join
- HIV infection
- Other forms of chronic liver disease
- Chronic medical conditions
- On immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
United States1 site
G.V. Sonny Montgomery VA Medical Center
Jackson, Mississippi, 39216
About this study
Official title: The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load
This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.
- Conditions
- Hepatitis C Virus Infection, Infection, Herpesvirus 2, Human
- Being tested
- Valacyclovir
- Keywords
- Herpes simplex type 2, Hepatitis C virus, Valacyclovir, Herpes Simplex virus type 2 infection
- Medical subject headings
- Hepatitis C, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
Also called VALTREX
Valacyclovir 500 mg, 2 caplets twice daily for eight weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of study participants who experience adverse events while receiving valacyclovir.
Tolerability assessments will be performed very two weeks while on study medications. Complete blood cell count, creatinine clearance and liver function tests will be performed every four weeks while on medications. Adverse events will be graded using the Division of AIDS Adverse Event Grading Table, Version 1.0, clarification August 2009. Based on previous clinical experience with valacyclovir, we expect the drug will be well-tolerated in patients with hepatitis C.
Measured: 18 weeks
Secondary outcomes (1)
The effect of valacyclovir compared with placebo to serum levels of HCV RNA
Serum HCV RNA will be measured at baseline and every four weeks while on study medication. We expect to see a decrease in HCV RNA >0.5 log10IU/mL during the valacyclovir phase compared with the placebo phase. The cross-over design will allow each patient to serve as their own control, providing data on the effect of HSV-2 suppression on HCV RNA.
Measured: 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startApr 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.V. (Sonny) Montgomery VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Wanda Hayes, G.V. (Sonny) Montgomery VA Medical Center
- Investigators
- Mary Jane Burton, M.D., Principal investigator, G.V. (Sonny) Montgomery VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037621
- Sponsor's protocol ID
- VAL R 152
- Other IDs
- 2009-00348, 2009
- Status last verified
- Nov 2011
- First submitted
- 22 Dec 2009
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load
- ClinicalTrials.gov ID
- NCT01037621
- Acronym / sponsor ID
- VAL R 152
- Conditions
- Hepatitis C Virus Infection, Infection, Herpesvirus 2, Human
- Keywords
- Herpes simplex type 2, Hepatitis C virus, Valacyclovir, Herpes Simplex virus type 2 infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- G.V. (Sonny) Montgomery VA Medical CenterUS federal agency
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of hepatitis C infection
- Clinical diagnosis of herpes simplex type 2 infection
Key exclusion criteria (4 listed)
- HIV infection
- Other forms of chronic liver disease
- Chronic medical conditions
- On immunosuppressive medications
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 |
|---|---|---|
| ValacyclovirAlso: VALTREXValacyclovir 500 mg, 2 caplets twice daily for eight weeks | Drug | – |
Primary outcome
The number of study participants who experience adverse events while receiving valacyclovir.
Time frame: 18 weeks
Tolerability assessments will be performed very two weeks while on study medications. Complete blood cell count, creatinine clearance and liver function tests will be performed every four weeks while on medications. Adverse events will be graded using the Division of AIDS Adverse Event Grading Table, Version 1.0, clarification August 2009. Based on previous clinical experience with valacyclovir, we expect the drug will be well-tolerated in patients with hepatitis C.
1 secondary outcome
The effect of valacyclovir compared with placebo to serum levels of HCV RNA
Time frame: 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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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 Jane Burton, M.D. principal investigator
G.V. (Sonny) Montgomery VA Medical Center
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 Hepatitis C Virus Infection and Infection, run by G.V. (Sonny) Montgomery VA Medical Center 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 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2011. 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. 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?
Results are not available in the source record.
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?
The number of study participants who experience adverse events while receiving valacyclovir. (time frame: 18 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 7 Nov 2011.