82
Participants
Start Date
October 13, 2010
Primary Completion Date
October 4, 2012
Study Completion Date
September 11, 2017
Atazanavir powder
Powder, oral, dosed by weight. Participants who weighed 5 to \<10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to \<15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to \<25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.
Ritonavir oral solution
Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.
Atazanavir capsules
Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (ATV). Patients who weighed 15 to \<20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to \<40 kg received ATV, 200 mg, and RTV, 100 mg; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
Ritonavir capsules
Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.
Local Institution, Lima
Local Institution, Soweto
Local Institution, Coronationville
Local Institution, KwaKhangela
Local Institution, Cape Town
Local Institution, Bloemfontein
Local Institution, Bangkok
Local Institution, Bangkok
Local Institution, Guadalajara
Local Institution, Guadalajara
Local Institution, Oaxaca City
Local Institution, Puebla City
Local Institution, Mérida
Local Institution, Santiago
Local Institution, São Paulo
Local Institution, Santiago
Local Institution, Lima
Local Institution, Df
Lead Sponsor
Bristol-Myers Squibb
INDUSTRY