Phase IIIB Pediatric ATV Powder for Oral Use (POU) (PRINCE2) - Full Text View

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 liquid and an optimized dual Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone in pediatric subjects ≥ 3 months to < 8 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) Liquid With an Optimized Nucleoside Reverse Transcriptase Inhibitor (NRTI) Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects Greater Than or Equal to 3 Months to Less Than 8 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE2 Study)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Atazanavir Atazanavir sulfate

U.S. FDA Resources

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: 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 ]

Estimated Enrollment:	75
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: Atazanavir+Ritonavir	Drug: Atazanavir Sulphate Powder, Oral, Dosed by weight 5- <10 kg = 150 mg, 10- <15 kg = 200 mg, 15- <25 kg = 250 mg, 25- <35 kg = 300 mg, Once daily, 48 weeks or until age of 8 years or weight ≥ 35 kg Other Names: Reyataz BMS-232632 Drug: Ritonavir Solution 80 mg/mL, Oral, Dosed by weight 5- <25 kg = 80 mg, 25- <35 kg = 100 mg, Once daily, 48 weeks or until age of 8 years or weight ≥ 35 kg Other Name: Norvir

Arms

Assigned Interventions

Experimental: Atazanavir+Ritonavir

Drug: Atazanavir Sulphate

Powder, Oral, Dosed by weight 5- <10 kg = 150 mg, 10- <15 kg = 200 mg, 15- <25 kg = 250 mg, 25- <35 kg = 300 mg, Once daily, 48 weeks or until age of 8 years or weight ≥ 35 kg

Other Names:

Reyataz
BMS-232632

Drug: Ritonavir

Solution 80 mg/mL, Oral, Dosed by weight 5- <25 kg = 80 mg, 25- <35 kg = 100 mg, Once daily, 48 weeks or until age of 8 years or weight ≥ 35 kg

Other Name: Norvir

Eligibility

Ages Eligible for Study:	3 Months to 90 Months
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 < 7 years 6 months of age
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.

Show 34 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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:	February 22, 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
Reverse Transcriptase Inhibitors
Ritonavir

Atazanavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 19, 2013