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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335698
First received: April 13, 2011
Last updated: October 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
HIV
Drug: Atazanavir Sulphate
Drug: Ritonavir
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The number of subjects who died [ Time Frame: Through a minimum of 24 weeks ] [ Designated as safety issue: Yes ]
  • The frequency of Serious Adverse Events (SAEs) [ Time Frame: Through a minimum of 24 weeks ] [ Designated as safety issue: Yes ]
  • The frequency of Adverse Events (AEs) leading to discontinuation [ Time Frame: Through a minimum of 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportions of subjects with HIV ribonucleic acid (RNA) <50 c/mL and <400 c/mL at weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of ATV powder boosted with RTV in pediatric subjects weighing 5 - <10 kg (200 mg ATV + 80 mg RTV), ≥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 (200 mg ATV + 80 mg RTV), ≥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 (200 mg ATV + 80 mg RTV), ≥25 - <35 kg and/or aged ≥6 - <11 years [ Time Frame: 2 weeks after reaching this weight/age band ] [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: May 2011
Estimated Study Completion Date: July 2018
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 minimum 24 weeks up to 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 minimum 24 weeks up to 48 weeks or weight ≥35 kg

OR

Ritonavir 100 mg capsule orally (dosed by weight 25- <35 kg = 100 mg) once daily for minimum 24 weeks up to 48 weeks or weight ≥35 kg

OR

Ritonavir 100 mg tablet orally (dosed by weight 25- <35 kg = 100 mg) once daily for minimum 24 weeks up to 48 weeks or weight ≥35 kg

Drug: Atazanavir Sulphate
Other Names:
  • Reyataz
  • BMS-232632
Drug: Ritonavir
Other Name: Norvir

  Eligibility

Ages Eligible for Study:   3 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335698

  Show 32 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01335698     History of Changes
Other Study ID Numbers: AI424-451, 2010-024537-23
Study First Received: April 13, 2011
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Pública de Chile
Mexico: Ethics Committee
Mexico: Ministry of Health
Mexico: Secretaria de Salud
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Keywords provided by Bristol-Myers Squibb:
Pediatric

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014