Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients

Status:	Completed
Conditions:	HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any - 11
Updated:	11/11/2018
Start Date:	May 27, 2011
End Date:	January 22, 2018

A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.(Pediatric Atazanavir International Clinical Evaluation: the PRINCE II Study)

The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a
regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse
transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Key Inclusion Criteria:

- Confirmed HIV-1 infection diagnosed by protocol criteria

- Screening HIV RNA level ≥1000 copies/mL

- ≥3 months to <11 years of age at time of first treatment

- Antiretroviral-naive or -experienced

- At screening, all participants must have genotypic sensitivity to atazanavir and at
least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved
for pediatric use at the local country.

- Antiretroviral-experienced patients must also have documented phenotypic sensitivity
at screening to atazanavir (Fold Change in susceptibility <2.2) and to at least 2
NRTIs that are approved in their country

Key Exclusion Criteria:

- Experienced participants who received atazanavir or atazanavir/ritonavir at any time
prior to study enrollment or who have a history of 2 or more protease inhibitor
failures

- Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to
study medications

- Cardiac rhythm abnormalities

- Need for tenofovir

- Weight <5 or ≥35kg

- >Grade 2 abnormality in aspartate transaminase/alanine transaminase levels

- Coinfection with either hepatitis B or C virus

- Any active Centers for Disease Control and Prevention Category C clinical condition

We found this trial at

sites

Local Institution

Buenos Aires, Bs As, Buenos Aires

from

Buenos Aires, Bs As,