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
  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: 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 95
Study Start Date: July 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: February 2015 (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 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

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

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

Contacts
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.

  Hide Study Locations
Locations
United States, District of Columbia
Children'S National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Natella Rakhmanina, Site 033    202-884-2130      
United States, New York
Suny Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Leonard B Weiner, Site 038    315-464-6331      
Argentina
Local Institution Recruiting
Buenos Aires, Bs As, Buenos Aires, Argentina, 1141
Contact: Site 039         
Local Institution Recruiting
Bunos Aires, Buenos Aires, Argentina, 1425
Contact: Site 001         
Local Institution Recruiting
La Plata, Buenos Aires, Argentina, 1900
Contact: Site 003         
Brazil
Local Institution Recruiting
Recife, Pernambuco, Brazil, 50070
Contact: Site 026         
Local Institution Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90020
Contact: Site 023         
Local Institution Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035
Contact: Site 025         
Local Institution Completed
Ribeirao Preto, Sao Paulo, Brazil, 14049
Local Institution Recruiting
Sao Paolo, Sao Paulo, Brazil, 01246
Contact: Site 024         
Chile
Local Institution Recruiting
Santiago, Metropolitana, Chile, 000
Contact: Site 005         
Local Institution Recruiting
Santiago, Metropolitana, Chile, 8380418
Contact: Site 004         
Mexico
Local Institution Recruiting
Df, Distrito Federal, Mexico, 06720
Contact: Site 029         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact: Site 022         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Site 020         
Local Institution Recruiting
Merida, Yucatan, Mexico, 97000
Contact: Site 048         
Local Institution Recruiting
Oaxaca, Mexico, 71256
Contact: Site 030         
Local Institution Not yet recruiting
Puebla, Mexico, 72000
Contact: Site 021         
Poland
Local Institution Recruiting
Warszawa, Poland, 01-201
Contact: Site 037         
Romania
Local Institution Recruiting
Bucharest, Romania, 72205
Contact: Site 017         
Russian Federation
Local Institution Recruiting
Smolensk, Russian Federation, 214006
Contact: Site 045         
Local Institution Recruiting
St-petersburg, Russian Federation, 198103
Contact: Site 041         
Local Institution Recruiting
St. Petersburg, Russian Federation, 189635
Contact: Site 018         
South Africa
Local Institution Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6001
Contact: Site 0051         
Local Institution Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6014
Contact: Site 043         
Local Institution Recruiting
Bloemfontein, Free State, South Africa, 9301
Contact: Site 014         
Local Institution Recruiting
Benoni, Gauteng, South Africa, 1501
Contact: Site 007         
Local Institution Recruiting
Pretoria, Gauteng, South Africa, 0001
Contact: Site 047         
Local Institution Recruiting
Soweto, Gauteng, South Africa, 2001
Contact: Site 006         
Local Institution Recruiting
Parrow Valley, Western Cape, South Africa, 7505
Contact: Site 010         
Spain
Local Institution Recruiting
Barcelona, Spain, 08950
Contact: Site 044         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 046         
United Kingdom
Local Institution Recruiting
Birmingham, West Midlands, United Kingdom, B9 5SS
Contact: Site 016         
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 1, 2013
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 Publica 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014