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Home > "A" Clinical Trials Conditions > A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children  A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
For Condition: HIV Infections
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 it is safe to give Varivax to HIV-positive children and whether it protects children from infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster). VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine that has been approved for use in healthy children. More research is needed to find out how this vaccine will affect HIV-infected children.
Details: Primary varicella infection, or chickenpox, can be devastating to HIV-infected children because complications occur at higher rates in immunocompromised hosts. Current passive prophylaxis measures with varicella-zoster immune globulin are suboptimal because administration must be repeated for each exposure during the child's lifetime and timely notification of exposure is not always possible. Since Varivax has been licensed for routine vaccination of healthy individuals, it must be determined whether this vaccine can be safely administered to HIV-infected children. Thirty-six children who are varicella zoster virus (VZV)-naive (treatment group) receive Varivax at Weeks 0 and 12, with a possible boost at Week 52 if the patient is still seronegative for VZV and cytomegalovirus infection. Twenty children who have a history of wild-type varicella exposure within the past year (control group) receive no study treatment. All patients are either asymptomatic or mildly symptomatic for HIV infection. Patients make 12-14 visits to the clinic. [AS PER AMENDMENT 9/9/99: This study has been reorganized into two cohorts (asymptomatic and symptomatic). In the asymptomatic cohort, accrual has been completed with 40 patients in Treatment Group I and 19 in the control group. This phase of the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with asymptomatic disease. The symptomatic cohort includes Treatment Groups II and III, each with 30 patients. The first 10 patients from Group II are monitored for 42 days following the first dose of vaccine before the remaining 20 are accrued. Once the first 10 patients in Group II have been evaluated with acceptable toxicity and immunologic profiles, the remaining 20 Group II and the first 10 Group III patients are enrolled. The first 10 Group III patients are also followed for acceptable toxicity and immunologic response before accrual of the remaining 20 Group III patients.]
Eligibility:
Study Type: Interventional, Prevention, Safety Study
Minimum Age/Maximum Age: 12 Months/8 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are HIV-positive with no symptoms or moderate symptoms. - Are between 1 and 8 years old (consent of parent or guardian required). - Have had a CD4 cell count greater than 200 for the past 3 months. If a child had a lower CD4 count before this time, then he/she must have been on stable anti-HIV therapy for the past 3 months. Exclusion Criteria Children will not be eligible for this study if they: - Have had an infection or a fever of 101 F or higher in the past 3 days. - Have had chickenpox or shingles. (This study has been changed. Children who had VZV infections were eligible originally.) - Have been exposed to chickenpox or shingles in the past 4 weeks. - Live with someone who is HIV-positive or who has a lowered immune system. - Have certain serious diseases including tuberculosis or a disease of the immune system (other than HIV infection). - Are allergic to any part of the chickenpox vaccine, including neomycin. - Have recently had certain treatments or might be taking certain treatments during the study such as aspirin, VZIG, IVIG, other vaccines, steroids, anti-herpes medications, blood products, or drugs that might interfere with the immune system.
Total Enrollment: 127
Location and Contact Information:
Overall Study Official:
MyronLevin, Study Chair,
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, 32503
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Montefiore Medical / AECOM
Bronx, New York, 19461
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Harbor - UCLA Med Ctr
Torrance, California, 90509
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
UCLA Med Ctr / Pediatrics
Los Angeles, California, 90095
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
New York Hosp - Cornell Med Ctr
New York City, New York, 10021
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Additional Information:
Study ID Numbers: ACTG 265; PACTG 265
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000837
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
2. A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2 -18 Years
3. A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
4. Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
5. A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
Related Studies:
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A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
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