Clinical trialNCT00004735CompletedInterventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment81HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Mona Rigaud, MD, MPH
NYU Langone Health
Study Chair
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William Borkowsky, MD
NYU Langone Health
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

27 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

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

United States

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
Bmc, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
Hms - Children'S Hosp. Boston, Div. of 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
Columbia Impaact Crs
New York, New York, United States
Harlem Hosp. Ctr. Ny Nichd Crs
New York, New York, United States
Nyu 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

HEPATITIS ATetanus toxoid vaccine, inactivated

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Feb 2000
Primary completion: —
Completion: 30 Sept 2006
Last update posted: 7 Oct 2013
Registered enrollment: 81
Registry id: NCT00004735

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Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.