Author Contributions: Dr Brogly had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design; critical revision of the
manuscript for important intellectual content: Brogly, Williams, Seage,
Oleske, Van Dyke, McIntosh.
Acquisition of data: Oleske, Van Dyke, McIntosh.
Analysis and interpretation of data: Brogly,
Williams, Seage, Oleske.
Drafting of the manuscript: Brogly.
Statistical analysis: Brogly, Williams.
Obtained funding: Oleske.
Administrative, technical, or material support:
Brogly, Oleske, Van Dyke.
Study supervision: Van Dyke, McIntosh.
Financial Disclosures: None reported.
Funding/Support: This study was funded by the
US National Institute of Allergy and Infectious Diseases and the National
Institute of Child Health and Human Development. This work was further supported
by Center for Biostatistics in AIDS Research at the Harvard School of Public
Health (the statistical and data analysis center of the Pediatric AIDS Clinical
Trials Group) under the National Institute of Allergy and Infectious Diseases
cooperative agreement 5 U01 AI41110.
Role of the Sponsors: The US National Institute
of Allergy and Infectious Diseases and the National Institute of Child Health
and Human Development were involved in the design, data collection, and conduct
of protocol 219C but were not involved in the present analysis, the interpretation
of the data, the writing of the manuscript, or the decision to submit for
Contributing PACTG 219C Site Personnel:University of Medicine & Dentistry of New Jersey: P.
Palumbo, P. Andrew, A. Dieudonne, B. Dashefsky; Robert Wood
Johnson Medical School: S. Gaur, P. Whitley-Williams, A. Malhotra,
L. Cerracchio; Harbor-UCLA Medical Center: M. Keller,
J. Hayes, A. Gagajena, C. Mink; Johns Hopkins University
Pediatrics: N. Hutton, B. Griffith, M. Joyner, C. Kiefner; Baylor Texas Children’s Hospital: F. Minglana, M. E. Paul, W.
T. Shearer, C. D. Jackson; Sinai Children’s Hospital: D. C. Johnson, D. Kowalski, B. Wolfe, D. Ryan; The Columbia Presbyterian Medical Center & Cornell University New York
Presbyterian Hospital: A. Higgins, M. Foca, P. LaRussa, A. Gershon; University of Miami: G. B. Scott, C. D. Mitchell, L. Taybo,
C. Gamber; Children’s Hospital & Research Center
at Oakland: A. Petru, T. Courville, K. Gold, L. Johnson; Phoenix Children’s Hospital: J. P. Piatt, J. Foti, L. Clarke-Steffen; University of North Carolina at Chapel Hill: T. Belho,
B. Pitkin, J. Eddleman; Schneider Children’s Hospital: V. R. Bonagura, S. J. Schuval, C. Colter; Harlem
Hospital: E. J. Abrams, M. Frere, D. Calo, S. Champion; The Children’s Hospital at Downstate: E. Handelsman, H. J. Moallem,
D. M. Swindell, J. M. Kaye; Jacobi Medical Center:
M. Chin, K. Dorio, A. Wiznia, M. Donovan; San Juan Hospital: M. Acevedo, M. Gonzalez, L. Fabregas, M. E. Texidor; Yale University School of Medicine: W. A. Andiman, S. Romano, L. Hurst,
J. de Jesus; SUNY Upstate Medical University: L.
B. Weiner, K. A. Contello, W. A. Holz, M. J. Famiglietti; SUNY Stony Brook: S. Nachman, D. Nikolic-Djokic, D. Ferraro, J. Perillo; Howard University: S. Rana, H. Finke-Castro, P. H. Yu,
J. C. Roa; University of Florida Health Science Center,
Jacksonville: M. H. Rathore, A. Khayat, K. Champion, S. Cusic; St Jude Children’s Research Hospital, Memphis: P.
M. Flynn, K. Knapp, N. Patel; Vanderbilt University Medical
Center: G. Wilson; Department of Pediatrics, Washington
University School of Medicine, St Louis Children’s Hospital:
K. A. McGann, L. Pickering, G. A. Storch; The Children’s
Hospital of Philadelphia: S. D. Douglas, G. Koutsoubis, R. M. Rutstein,
C. A. Vincent; Charity Hospital of New Orleans & Earl
K. Long Early Intervention Clinic: M. Silio, T. Alchediak, C. Boe,
M. Cowie; Baystate Medical Center Children’s Hospital: B. W. Stechenberg, D. J. Fisher, A. M. Johnston, M. Toye; Medical College of Georgia: C. S. Mani, S. Foshee, B. Kiean, S. Cobb; University of Maryland Medical Center: J. Farley, K. Klipner.
PACTG Centers: Cooper Hospital–University Medical
Center; Children’s Hospital Boston; Boston Medical Center; UCLA Medical
Center; Children’s Hospital of Los Angeles; Long Beach Memorial; Chicago
Children’s Memorial Hospital; Cook County Hospital; The University of
Chicago Children’s Hospital; Mount Sinai Medical Center, Womens &
Children’s HIV Program; UCSF, Moffitt Hospital; UCSD Mother, Child &
Adolescent HIV Program; Phoenix Children’s Hospital; Duke University;
New York University School of Medicine/Bellevue Hospital; Children’s
National Medical Center; Children's Hospital and Regional Medical Center,
Washington, DC; University of South Florida; Oregon Health and Science University;
Children’s Hospital of the King’s Daughters; Lincoln Medical &
Mental Health Center; University of Illinois; Children’s Hospital of
Michigan; Children’s Medical Center of Dallas; Los Angeles County Medical
Center/USC; Children’s Hospital, University of Colorado, Denver; North
Broward Hospital District; University of Florida at Gainesville; University
of Rochester Medical Center; University of Mississippi Medical Center; Medical
College of Virginia; University of Puerto Rico, University Children’s
Hospital AIDS Program; St Christopher’s Hospital for Children, Philadelphia;
Bronx Lebanon Hospital Center; St Luke’s/Roosevelt Hospital Center;
Montefiore Medical–AECOM; Metropolitan Hospital Center; University of
Massachusetts Medical School; Connecticut Children’s Medical Center;
University of Alabama at Birmingham; University of South Alabama; The Medical
Center, Pediatric Columbus, Georgia; Incarnation Children’s Center,
New York; St Joseph’s Hospital and Medical Center, New Jersey; Children’s
Hospital of Oakland; Emory University Hospital; Ruiz Arnau University Hospital;
Medical University of South Carolina; Children’s Hospital at Albany
Medical Center; Columbus Children’s Hospital; Public Health Unit of
Palm Beach County; Children’s Hospital of Los Angeles.
Acknowledgment: We thank the children and families
for their participation in PACTG 219C and the individuals and institutions
involved in the conduct of 219C.