PHASE I/II, OPEN LABEL, PHARMACOKINETIC AND SAFETY STUDY OF A NOVEL PROTEASE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is the first pediatric trial of the new HIV protease inhibitor, atazanavir. The study will test different dosages, capsule versus powder formulation, and with and without the boosting drug, ritonavir. All subjects are children 3 months to 21 years of age who are infected with HIV and will receive the new drug with 2 other HIV drugs. The study will determine the dosage, safety, and effectiveness of this new drug in children.