The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00004735

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

81

Starts

2000-02-01

Expected to finish

2006-09-01

Last updated by the study team

2013-10-07

Who can join

Age: 2 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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