The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV
NCT ID: NCT00004735
Last Updated: 2013-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2000-02-29
2006-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Tetanus toxoid
Hepatitis A Vaccine (Inactivated)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
24 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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William Borkowsky, MD
Role: STUDY_CHAIR
NYU Langone Health
Mona Rigaud, MD, MPH
Role: STUDY_CHAIR
NYU Langone Health
Locations
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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
UW School of Medicine - CHRMC
Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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References
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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.
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.
Other Identifiers
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10036
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1006
Identifier Type: -
Identifier Source: org_study_id