BIOLOGICAL
The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV
Status
Completed
Phase
Not applicable
Enrollment
81
Locations
27
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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.
Full detailed description
HIV damages the immune system by infecting CD4 cells, white blood cells that help fight infections and protect the body from disease. As CD4 cells die, the immune system becomes weak. Taking anti-HIV drugs slows the ability of the virus to multiply and kill CD4 cells. HIV infected children taking anti-HIV drugs have significant inhibition of HIV growth and significant increases in CD4 cell counts. It is not known to what extent CD4 count increases in HIV infected children translate to functional immune recovery. HIV infected children have typically demonstrated poor serological responses to routine childhood immunizations. Participants will either begin HAART or make a change to their current HAART regimens at study entry or within 2 weeks prior to study entry. All participants will have viral load testing when they begin or change their HAART regimens. Participants will then have a second viral load test after 4 weeks. Only participants with an acceptable decrease in viral load will continue in the study. Participants will be randomly assigned to one of two groups. Participants in Group 1 will receive tetanus toxoid immunizations (known as DTaP, DT-pediatric, or Td) at Weeks 8, 16, and 24 and hepatitis A vaccinations at Weeks 32, 40, and 48. Participants in Group 2 will receive hepatitis A vaccinations at Weeks 8, 16, and 24 and tetanus toxoid immunizations at Weeks 32, 40, and 48. Participants will have a physical exam and blood tests at study entry and at Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 48, 52, 76, and 100. As of May 2005, participants will have the option to receive an additional hepatitis A vaccination booster. Those who consent and have not reached Week 100 of the study will receive a booster vaccination at Week 100, with a final follow-up visit occuring at Week 104. Those participants who do not consent will not receive the hepatitis A vaccination booster and will have their last follow-up visit at Week 100.
Interventions
Treatment arms and agents.
BIOLOGICAL
Hepatitis A Vaccine (Inactivated)
Timeline
From registration to results.
First posted
Aug 31, 2001
Study start
Feb 2000
Primary completion
Not reported
Study completion
Sep 2006
Results posted
Not reported
Registry updated
Oct 7, 2013
Outcomes
What the study measures.
Primary outcomes
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
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
Eligibility
Who can take part.
- Minimum age
- 2 Years
- Maximum age
- 24 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria * 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 Exclusion Criteria * 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
Study locations
27 registered sites.
Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States
Usc La Nichd Crs
Alhambra, California, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
USF - Tampa NICHD CRS
Tampa, Florida, United States
Chicago Children's CRS
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States
Nyu Ny Nichd Crs
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
Publications
Results and literature.
PMID 12777579 ↗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 18752430 ↗Rigaud 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.
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