Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
Completed · Phase 1/Phase 2
Conditions studied: HIV Infections
In brief
The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
Key facts
- Study ID
- NCT00006604
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 195
- Starts
- 2000-11-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2021-11-05
Who can join
Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UAB Pediatric Infectious Diseases CRS — Birmingham, Alabama, United States
- Usc La Nichd Crs — Alhambra, California, United States
- University of California, UC San Diego CRS — La Jolla, California, United States
- Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach, California, United States
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
- Univ. of California San Francisco NICHD CRS — San Francisco, California, United States
- Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, 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
- Columbus Regional HealthCare System, The Med. Ctr. — Columbus, Georgia, United States
- Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago, Illinois, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS — Chicago, Illinois, United States
- Tulane Univ. New Orleans NICHD CRS — New Orleans, Louisiana, United States
- Univ. of Maryland Baltimore NICHD CRS — Baltimore, Maryland, United States
- Johns Hopkins Univ. Baltimore NICHD CRS — Baltimore, Maryland, United States
- Boston Medical Center Ped. HIV Program NICHD CRS — Boston, Massachusetts, United States
- WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
- Rutgers - New Jersey Medical School CRS — Newark, New Jersey, United States
- Nyu Ny Nichd Crs — New York, New York, United States
- Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
- SUNY Upstate Med. Univ., Dept. of Peds. — Syracuse, New York, United States
- Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
- Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
- DUMC Ped. CRS — Durham, North Carolina, United States
- Philadelphia IMPAACT Unit CRS — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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