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Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox Clinical research trials and Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox. Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox clinical trial. Human subjects often obtain the finest healthcare possible for their Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox  Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
For Condition: HIV Infections,Chickenpox
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to see if the varicella-zoster virus (VZV) vaccine will be safe and if it can help prevent shingles in HIV-infected children who have already had chickenpox. VZV is the virus that causes chickenpox. If this virus is reactivated in the body, it can also cause shingles. Shingles is common in children with HIV who have had chickenpox, although it is usually not life-threatening. The VZV vaccine used in this study may be able to prevent HIV-positive children who have had chickenpox from developing shingles.
Details: Varicella (chickenpox) results from primary infection with VZV. Varicella, a common and usually benign illness in normal children, is more severe in HIV-infected children and may result in other conditions such as HZ (shingles). HZ is due to reactivation of latent VZV acquired during varicella and is common in HIV-infected children who have had natural varicella. While HZ is not likely to be life-threatening in these children, it does cause considerable morbidity and interferes with quality of life. Use of a live-attenuated VZV vaccine may be able to boost immunity in these children. Two immunologic cohorts are enrolled. Cohort A includes children with a CD4 cell percentage greater than or equal to 20 percent that has been documented as stable for at least the 6 months prior to the time varicella developed (confirmed by a minimum of 2 tests) and a CD4 cell percentage greater than [AS PER AMENDMENT 10/27/99: or equal to] 15 percent that has been documented as stable for at least the 6 months prior to enrollment (confirmed by a minimum of 2 tests). Cohort B includes children with a CD4 cell percentage greater than or equal to 10 percent and less than 15 percent that has been documented as stable for at least the 6 months prior to the time varicella developed and stable for at least the 6 months prior to enrollment (confirmed by a minimum of 2 tests). [AS PER AMENDMENT 4/20/01: Cohort B includes children who have a CD4 cell percentage less than 15% documented by a minimum of 1 but preferably 2 tests within 1 year of onset of varicella (i.e., within 1 year before to 1 year after varicella) and a CD4 cell percentage greater than or equal to 15% documented by a minimum of 2 tests at the time of enrollment.] A pilot study precedes the full study. [AS PER AMENDMENT 10/27/99: The pilot study for Cohort A precedes the full study for Cohort A and the pilot study for Cohort B. The pilot study for Cohort B precedes the full study for Cohort B.] The pilot study includes 10 children from each cohort who receive live-attenuated VZV at Weeks 0 and 8. If 3 pilot-study patients in a cohort meet a toxicity endpoint related to the vaccine, the dose regimen has failed the safety criteria for that cohort. [AS PER AMENDMENT 10/27/99: If 3 children in the pilot study for Cohort A meet a toxicity endpoint deemed to be related to the vaccine, the dose regimen has failed safety criteria for both cohorts. If 3 children in the pilot phase of Cohort B meet a toxicity endpoint deemed related to the vaccine, the dose regimen has failed the safety criteria for Cohort B.] If, at 12 weeks after immunization, at least 5 pilot-study patients in a cohort respond and the safety profile is deemed adequate, the pilot study extends into a full study with the immunization of an additional 20 patients from that cohort. [AS PER AMENDMENT 10/27/99: If, at Week 12, at least 5 pilot-study patients in Cohort A meet immunologic criteria and the safety profile is deemed adequate, then the full study for Cohort A and the pilot study for Cohort B opens. If the same immunologic and safety criteria are met for the pilot study for Cohort B, then the full study for Cohort B opens.] If either cohort shows an inadequate immunologic response or safety profile, the study team reviews the results to determine if another regimen should be considered. In the full study, patients receive 2 immunizations, at Weeks 0 and 8. Varicella antibody titers and in vitro responder cell frequency (RCF) assays are measured at Weeks 0, 4, 8, 12, 24, 52, 78, and 104. Symptoms, HIV progression, and VZV presence are monitored throughout the study.
Eligibility:
Study Type: Interventional, Prevention, Open Label
Minimum Age/Maximum Age: 2 Years/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are 2 to 18 years old (need consent of parent or guardian if under 18). - Are HIV-positive. - Are VZV-positive. - Have a CD4 cell percentage of at least 15 percent at the time of enrollment. (This criterion reflects a change from the original CD4 cell percentage.) - Have been receiving stable anti-HIV therapy for at least 3 months, with no plans to change these medications. - Had chickenpox at least 6 months prior to study entry. - Were at least 1 year old when they had chickenpox. - Agree to use a barrier method of birth control (such as a condom) during the study. Exclusion Criteria Children will not be eligible for this study if they: - Have an active infection within 72 hours of study entry. - Have a fever over 101 F within 72 hours of study entry. - Were exposed to chickenpox or shingles within 4 weeks prior to study entry. - Have ever had shingles. - Live with someone who has HIV, or who has a weak immune system, and has never had chickenpox. - Have taken certain medications that affect the immune system, such as steroids, within 30 days of study entry. - Have taken or are planning to take VZIG or IVIG within 1 year prior to or 2 months after a study vaccination. - Are allergic to the vaccine, or to neomycin. - Have received or expect to receive another vaccine within 30 days prior to or 30 days after a study vaccination. - Have ever received a chickenpox vaccine. - Are taking aspirin or expect to use aspirin 6 weeks after a study vaccination. - Have taken or plan to take any anti-herpes drugs within 1 week before or 3 weeks after a study vaccination. - Have received or plan to receive a blood transfusion within 1 year before or 2 months after a study vaccination. - Have certain medical problems that would interfere with the study. - Are pregnant or breast-feeding.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
AnneGershon, Study Chair,
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, 32503
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
New York Hosp - Cornell Med Ctr
New York City, New York, 10021
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, 08103
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372322581
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Additional Information:
Study ID Numbers: ACTG 391; PACTG 391
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001125
Other Chickenpox Studies:
1. A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success with or Who Cannot Take Other Treatments for VZV
2. A Study of the Safety and Effectiveness of Varivax (the Chicken Pox Vaccine) in Children Who Have Received Kidney Transplants
3. Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
4. A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients with Weakened Immune Systems
5. Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
Related Studies:
Other Chickenpox Clinical Trials
Other New York Clinical Trials
Other Albany Clinical Trials
Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
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