Herpes SimplexPhase 3NCT00006132
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
A Phase 3 study testing acyclovir in people with Herpes Simplex, run by National Center for Research Resources (NCRR) at 28 sites in 2 countries.
Trial summary
OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system. II. Determine whether neurologic outcome is improved in these patients when treated with this regimen. III. Read more about this study
- Who is it for?
- Ages 0 years to 28 days
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- acyclovir
- How many people
- 132 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Jun 1997to not given
- Phase
- Phase 3
- 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 0 years to 28 days
- All sexes
- No healthy volunteers
- Child
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Infants diagnosed with herpes simplex virus infection involving the central nervous system with or without evidence of viral dissemination to other organs (i.e., skin, liver, or lungs) HSV-1 or HSV-2 isolated from cutaneous lesions from any site (skin, oropharynx, cerebrospinal fluid (CSF), urine, etc.) OR Must have positive CSF polymerase chain reaction (PCR) if no cutaneous skin lesions are present and viral cultures are negative No infection limited to skin, eyes, or mouth Evidence of CNS involvement includes one or more of the following: Abnormal CSF indices for term infants (WBC greater than 22/mm3 and protein greater than 115 mg/dL) Abnormal CSF indices for preterm infants (WBC greater than 25/mm3 and protein greater than 220 mg/dL) Abnormal neuroimaging study (CT with contrast, MRI with gadolinium, or head ultrasound) Disseminated disease is defined as one or more of the following: SGPT at least 2.5 times upper limit of normal Pneumonia/pneumonitis Necrotizing enterocolitis Disseminated intravascular coagulopathy
- Birth weight at least 800 grams
--Prior/Concurrent Therapy--
- No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days
--Patient Characteristics--
- Renal: Creatinine no greater than 1.5 mg/dL
- Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage
- Other: No infants known to be born to HIV positive women
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States26 sites, 24 recruiting
- Recruiting
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Richard J. Whitley, 205-934-5316
- Recruiting
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
David W. Kimberlin, 205-939-6097
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
Sandra Fowler, 843-792-2385
- Recruiting
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Amina Ahmed, 704-355-1301
- Recruiting
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
Lawrence Stanberry, 513-559-6773
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Mary Lou Kumar, 216-778-4284
- Recruiting
Ohio State University Children's Hospital
Columbus, Ohio, 43205-2696
Dwight Powell, 614-722-4450
- Recruiting
University of Texas Southwestern Medical School
Dallas, Texas, 75235-9032
Pablo J. Sanchez, 214-648-3753
- Recruiting
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
Mark Shelton, 817-885-4000
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Alberto Cohen-Abbo, 860-545-9330
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Gail Demmler, 713-770-4330
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
April Palmer, 601-984-5206
- Active, not recruiting
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
- Recruiting
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, 37920
Thomas Smith, 423-544-9356
- Recruiting
University of Arkansas
Little Rock, Arkansas, 72202
Richard Jacobs, 501-320-1416
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Elias J. Anaissie, 501-686-8274
- Completed
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232-6305
Kathy Edwards, 615-322-2250
- Recruiting
Tulane University Medical Center
New Orleans, Louisiana, 70112
Rusell Van Dyke, 504-588-5422
- Recruiting
Maine Medical Center
Portland, Maine, 04102
Carol McCarthy, 207-828-8226
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Penelope H. Dennehy, 401-444-4298
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
Charles Leach, 210-567-5246
- Recruiting
Children's Hospital and Health Center
San Diego, California, 92123-4282
John Bradley, 619-576-5823
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
Gregory Storch, 314-454-6079
- Recruiting
Stanford University
Stanford, California, 94305
Ann Arvin, 650-723-5682
- Recruiting
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Leonard Weiner, 315-464-6331
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2R7
Joan Robinson, 780-492-1680
- Recruiting
University of Manitoba-Winnipeg
Winnipeg, Manitoba, R3A 1R9
Amin Kabani, 204-787-1928
About this study
OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system.
II. Determine whether neurologic outcome is improved in these patients when treated with this regimen.
III. Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients.
IV. Determine the safety of this regimen in these patients.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to disease (CNS disease with or without cutaneous involvement vs disseminated disease with CNS involvement).
All patients receive acyclovir IV every 8 hours on days 1-21. On day 19, patients undergo a lumbar puncture and must have a negative CSF PCR to be randomized. If patients have a positive CSF PCR on day 19, they continue to receive acyclovir IV every 8 hours. Treatment continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR result is achieved. Patients are then randomized to one of two treatment arms.
Arm I: Patients receive oral acyclovir three times a day for 6 months. Arm II: Patients receive placebo. In case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive) for 5 days. Patients may or may not continue on study drug following this treatment.
Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.
- Conditions
- Herpes Simplex
- Being tested
- acyclovir
- Keywords
- herpes simplex virus infection, herpes virus infection, immunologic disorders and infectious disorders, rare disease, viral infection
- Medical subject headings
- Herpes Simplex, Herpesviridae Infections, Immune System Diseases, Communicable Diseases, Rare Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acyclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2000 (estimated)
- Study startJun 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies 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 3
- Primary purpose
- Treatment
- Enrolment
- 132 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Alabama at Birmingham
- Investigators
- David W. Kimberlin, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006132
- Sponsor's protocol ID
- 199/15325
- Other IDs
- UAB-CASG-103
- Status last verified
- Dec 2003
- First submitted
- 3 Aug 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
- ClinicalTrials.gov ID
- NCT00006132
- Acronym / sponsor ID
- 199/15325
- Conditions
- Herpes Simplex
- Keywords
- herpes simplex virus infection, herpes virus infection, immunologic disorders and infectious disorders, rare disease, viral infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Alabama at Birmingham
- Study start
- Jun 1997
- First posted
- 4 Aug 2000 (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.
OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system.
II. Determine whether neurologic outcome is improved in these patients when treated with this regimen.
III. Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients.
IV. Determine the safety of this regimen in these patients.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to disease (CNS disease with or without cutaneous involvement vs disseminated disease with CNS involvement).
All patients receive acyclovir IV every 8 hours on days 1-21. On day 19, patients undergo a lumbar puncture and must have a negative CSF PCR to be randomized. If patients have a positive CSF PCR on day 19, they continue to receive acyclovir IV every 8 hours. Treatment continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR result is achieved. Patients are then randomized to one of two treatment arms.
Arm I: Patients receive oral acyclovir three times a day for 6 months. Arm II: Patients receive placebo. In case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive) for 5 days. Patients may or may not continue on study drug following this treatment.
Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 0 years to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| acyclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
David W. Kimberlin study chair
University of Alabama at Birmingham
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acyclovir in people with Herpes Simplex, run by National Center for Research Resources (NCRR) at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 24 Jun 2005.