Clinical trial NCT01335698: Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: Pediatric
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
timeFrame: Day one to week 300 (approximately 22-Jan-2018)
measure: Number of Participants Who Experienced a SAE on ATV Powder
timeFrame: Day one to week 300 (approximately 22-Jan-2018)
measure: Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
timeFrame: Day one to week 300 (approximately 22-Jan-2018)
measure: Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
timeFrame: Day one to week 300 (approximately 22-Jan-2018)
Secondary outcomes:
measure: Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
timeFrame: Day 1 of treatment to weeks 24 and 48
measure: Mean Change From Baseline in HIV RNA on ATV Powder
timeFrame: Baseline to Weeks 24 and 48
measure: Mean Change From Baseline in CD4 Percent on ATV Powder
timeFrame: Baseline to Weeks 24 and 48
measure: CD4 Cell Count Changes From Baseline on ATV Powder
timeFrame: Baseline to Weeks 24 and 48
measure: Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
timeFrame: Baseline through Week 48
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Baseline to Week 2
measure: Minimum Plasma Concentration (Cmin)
timeFrame: Baseline to Week 2
measure: Area Under the Concentration-Time Curve [AUC(TAU)]
timeFrame: Baseline to Week 2
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children'S National Medical Center
state: District of Columbia
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Buenos Aires, Bs As
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Bunos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Recife
country: Brazil
facility: Local Institution
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Ribeirao Preto
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Oaxaca
country: Mexico
facility: Local Institution
city: Puebla
country: Mexico
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern CAPE
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern CAPE
city: Bloemfontein
country: South Africa
facility: Local Institution
state: FREE State
city: Benoni
country: South Africa
facility: Local Institution
state: Gauteng
city: Coronationville
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Parrow Valley
country: South Africa
facility: Local Institution
state: Western CAPE
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Birmingham
country: United Kingdom
facility: Local Institution
state: WEST Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: