Phase IIIB Pediatric ATV Powder for Oral Use (POU) (PRINCE2)

This study is currently recruiting participants.
Verified October 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335698
First received: April 13, 2011
Last updated: October 1, 2013
Last verified: October 2013

April 13, 2011
October 1, 2013
July 2011
February 2015   (final data collection date for primary outcome measure)
  • The number of subjects who died [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • The frequency of Serious Adverse Events (SAEs) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • The frequency of Adverse Events (AEs) leading to discontinuation [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
The frequency of serious adverse events, of Adverse event (AE)s leading to discontinuation, of AEs and of laboratory abnormalities. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01335698 on ClinicalTrials.gov Archive Site
  • Proportions of subjects with HIV ribonucleic acid (RNA) < 50 c/mL and < 400 c/mL at week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of ATV powder boosted with RTV in pediatric subjects weighing 5 - <10 kg, ≥25 - <35 kg and/or aged ≥6 - <11 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) of ATV powder boosted with RTV in pediatric subjects weighing 5 - <10 kg, ≥25 - <35 kg and/or aged ≥6 - <11 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) of ATV powder boosted with RTV in pediatric subjects weighing 5 - <10 kg, ≥25 - <35 kg and/or aged ≥6 - <11 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
  • Proportions of subjects with HIV ribonucleic acid (RNA) < 50 c/mL and < 400 c/mL at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • ATV maximum concentration of drug (Cmax) for subjects weighing ≥ 25 - <35 kg and/or aged ≥ 6 - < 8 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
  • ATV minimum concentration of drug (Cmin) for subjects weighing ≥ 25 - <35 kg and/or aged ≥ 6 - < 8 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
  • ATV area under the curve (AUC) for subjects weighing ≥ 25 - <35 kg and/or aged ≥ 6 - < 8 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase IIIB Pediatric ATV Powder for Oral Use (POU) (PRINCE2)
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 pharmacokinetic profile of a regimen consisting of Atazanavir powder boosted with Ritonavir and an optimized dual Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone in pediatric subjects ≥3 months to <11 years of age.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Drug: Atazanavir Sulphate
    Other Names:
    • Reyataz
    • BMS-232632
  • Drug: Ritonavir
    Other Name: Norvir
Experimental: Stage 1: Atazanavir+Ritonavir

Atazanavir powder orally (dosed by weight 5- <10 kg = 150 mg, 5- <10 kg = 200 mg, 10- <15 kg = 200 mg, 15- <25 kg = 250 mg, 25- <35 kg = 300 mg) once daily for 48 weeks or weight ≤35 kg

Ritonavir 80 mg/mL solution orally (dosed by weight 5- <25 kg = 80 mg, 25- <35 kg = 100 mg) once daily for 48 weeks or weight ≤35 kg

OR

Ritonavir 100 mg capsule orally (dosed by weight 25- <35 kg = 100 mg) once daily for 48 weeks or weight ≥35 kg

OR

Ritonavir 100 mg tablet orally (dosed by weight 25- <35 kg = 100 mg) once daily for 48 weeks or weight ≥35 kg

Interventions:
  • Drug: Atazanavir Sulphate
  • Drug: Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
95
July 2018
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed HIV 1 infection diagnosed by protocol criteria
  • Screening HIV RNA ≥ 1000 copies/mL
  • ≥3 months to <11 years of age at time of first treatment
  • Antiretroviral naive or experienced
  • All subjects must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country.
  • Antiretroviral-experienced subjects must also have documented phenotypic sensitivity at screening to ATV (Fold Change in susceptibility <2.2) and to at least 2 NRTIs that are approved in their country

Exclusion Criteria:

  • Experienced subjects who received ATV or ATV/RTV at any time prior to study enrollment or who have prior history of 2 or more protease inhibitor (PI) failures
  • Antiretroviral-naïve or experienced HIV-1 infected patients with contraindication to study medications
  • Cardiac rhythm abnormalities
  • Need for Tenofovir
  • Weight <5kg or ≥35kg
  • >Grade 2 aspartate transaminase (SGOT)[AST]/alanine transaminase (SGPT)[ALT]
  • Coinfection with either hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Any active Centers for Disease Control and Prevention (CDC) Category C clinical condition
Both
3 Months to 11 Years
No
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
United States,   Argentina,   Brazil,   Chile,   Mexico,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   United Kingdom
 
NCT01335698
AI424-451, 2010-024537-23
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP