The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV
The Effects of Highly Active Antiretroviral Therapy (HAART) on the Recovery of Immune Function in HIV-Infected Children and Young Adults
2 other identifiers
interventional
81
2 countries
27
Brief Summary
The purpose of this study is to determine the number of newly formed CD4 cells in children who have taken anti-HIV drugs. The study will also evaluate the effectiveness of the new CD4 cells in producing an immune response to hepatitis A and tetanus toxoid vaccination. Study hypothesis: 1) Immunologic reconstitution of individuals who have less than 15% CD4 cells may or may not be associated with functional activity. 2) The functional immunologic responses to recall and newly experienced antigens may be different. 3) The functional responses to antigens delivered in vaccine format may be a function of CD4 level, viral load, or both.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Feb 2000
Longer than P75 for not_applicable hiv-infections
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 25, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedOctober 7, 2013
October 1, 2013
February 25, 2000
October 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
A stimulation index of 3 or greater on at least 2 occasions to tetanus
positive serologic response to hepatitis A
four-fold increase over baseline in antibody titers for tetanus
Secondary Outcomes (3)
A stimulation index of 3 or greater on at least 2 occasions to hepatitis A and Candida
increase in CD4 cell percentage by 10% and absolute CD4 number by 150 cells/ml
development of any adverse events of Grade 3 or higher attributable to vaccination
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- CD4 percentage less than 15%
- Beginning an anti-HIV drug regimen (HAART) that includes at least 3 drugs. Two of the drugs must be new to the patient. One of the new drugs must be a protease inhibitor or a nonnucleoside reverse transcriptase inhibitor (NNRTI). As of May 2005, patients who have previously taken NNRTIs will have the option of taking Fuzeon as an alternative component of their HAART regimen
- Consent of parent or legal guardian
- As of May 2005, females who become pregnant during the study can continue to participate as long as they become pregnant after receiving all vaccinations
You may not qualify if:
- Active opportunistic (AIDS-related) or bacterial infection
- Cancer
- Immunity to hepatitis A
- Severe drug toxicity
- Previous severe or allergic reaction to tetanus vaccine
- Taking IVIG, IL-2, or other drugs which affect the immune system
- Taking hydroxyurea
- Pregnancy at screening visit
- Pregnancy before all vaccinations have been administered
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35233, United States
Usc La Nichd Crs
Alhambra, California, 91803, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801, United States
UCSF Pediatric AIDS CRS
San Francisco, California, 94143, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80218, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33316, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, 32610, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161, United States
USF - Tampa NICHD CRS
Tampa, Florida, 33606, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 21287, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01605, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, 11040, United States
Nyu Ny Nichd Crs
New York, New York, 10016, United States
Columbia IMPAACT CRS
New York, New York, 10032, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 14642, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
UW School of Medicine - CHRMC
Seattle, Washington, 98105, United States
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00936, Puerto Rico
Related Publications (2)
Melvin AJ, Mohan KM. Response to immunization with measles, tetanus, and Haemophilus influenzae type b vaccines in children who have human immunodeficiency virus type 1 infection and are treated with highly active antiretroviral therapy. Pediatrics. 2003 Jun;111(6 Pt 1):e641-4. doi: 10.1542/peds.111.6.e641.
PMID: 12777579BACKGROUNDRigaud M, Borkowsky W, Muresan P, Weinberg A, Larussa P, Fenton T, Read JS, Jean-Philippe P, Fergusson E, Zimmer B, Smith D, Kraimer J; Pediatrics AIDS Clinical Trials Group P1006 Team. Impaired immunity to recall antigens and neoantigens in severely immunocompromised children and adolescents during the first year of effective highly active antiretroviral therapy. J Infect Dis. 2008 Oct 15;198(8):1123-30. doi: 10.1086/592050.
PMID: 18752430RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William Borkowsky, MD
NYU Langone Health
- STUDY CHAIR
Mona Rigaud, MD, MPH
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2000
First Posted
August 31, 2001
Study Start
February 1, 2000
Study Completion
September 1, 2006
Last Updated
October 7, 2013
Record last verified: 2013-10