102
Participants
Start Date
October 31, 2007
Primary Completion Date
June 30, 2013
Study Completion Date
June 30, 2013
Early Initiation of Highly Active Anti-Retroviral Therapy
Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.
Standard Care
Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years.
Mount Sinai Medical Center, New York
Montefiore Medical Center, The Bronx
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
Howard University - IMPAACT Site, Washington D.C.
University of Maryland, Baltimore
Johns Hopkins University - IMPAACT Site, Baltimore
Duke Pediatric Infectious Diseases - IMPAACT Site, Durham
University of Miami, Miami
Children's Diagnostic and Treatment Center, Fort Lauderdale
University of Southern Florida College of Medicine, Tampa
St. Jude Children's Research Hospital (Memphis) - IMPAACT Site, Memphis
St. Jude Childrens Research Hospital, Memphis
Children's Hospital of Michigan - IMPAACT Site, Detroit
Stoger Hospital of Cook County, Chicago
Childrens Memorial Hospital, Chicago
Tulane Medical Center, New Orleans
Children's Hospital of Denver - IMPAACT Site, Aurora
Children's Hopsital of Los Angeles, Los Angeles
University of Southern California - IMPAACT Site, Los Angeles
University of California at San Francisco, San Francisco
UMDNJ - IMPAACT Site, Newark
University of Puerto Rico, San Juan
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
University of North Carolina, Chapel Hill
OTHER