PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)

PHASE3CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

October 13, 2010

Primary Completion Date

October 4, 2012

Study Completion Date

September 11, 2017

Conditions
HIV Infections
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Ritonavir capsules

Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.

Trial Locations (18)

1

Local Institution, Lima

2001

Local Institution, Soweto

2092

Local Institution, Coronationville

4013

Local Institution, KwaKhangela

7505

Local Institution, Cape Town

9301

Local Institution, Bloemfontein

10330

Local Institution, Bangkok

10700

Local Institution, Bangkok

44160

Local Institution, Guadalajara

44280

Local Institution, Guadalajara

71256

Local Institution, Oaxaca City

72000

Local Institution, Puebla City

97000

Local Institution, Mérida

8380418

Local Institution, Santiago

01246-900

Local Institution, São Paulo

Unknown

Local Institution, Santiago

Local Institution, Lima

06720

Local Institution, Df

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY