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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: Atazanavir Sulphate (Drug); Ritonavir (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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.

Clinical Details

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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The number of subjects who died

The frequency of Serious Adverse Events (SAEs)

The frequency of Adverse Events (AEs) leading to discontinuation

Secondary outcome:

Proportions of subjects with HIV ribonucleic acid (RNA) <50 c/mL and <400 c/mL at weeks 24 and 48

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

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

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

Eligibility

Minimum age: 3 Months. Maximum age: 11 Years. Gender(s): Both.

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

Locations and Contacts

Local Institution, Oaxaca 71256, Mexico

Local Institution, Puebla 72000, Mexico

Local Institution, Warszawa 01-201, Poland

Local Institution, Bucharest 72205, Romania

Local Institution, Smolensk 214006, Russian Federation

Local Institution, St. Petersburg 189635, Russian Federation

Local Institution, St.petersburg 198103, Russian Federation

Local Institution, Barcelona 08950, Spain

Local Institution, Madrid 28041, Spain

Local Institution, Buenos Aires, Bs As, Buenos Aires 1141, Argentina

Local Institution, Bunos Aires, Buenos Aires 1425, Argentina

Children'S National Medical Center, Washington, District of Columbia 20010, United States

Local Institution, Df, Distrito Federal 06720, Mexico

Local Institution, Port Elizabeth, Eastern Cape 6001, South Africa

Local Institution, Port Elizabeth, Eastern Cape 6014, South Africa

Local Institution, Bloemfontein, Free State 9301, South Africa

Local Institution, Benoni, Gauteng 1501, South Africa

Local Institution, Coronationville, Gauteng 2092, South Africa

Local Institution, Pretoria, Gauteng 0001, South Africa

Local Institution, Soweto, Gauteng 2001, South Africa

Local Institution, Guadalajara, Jalisco 44160, Mexico

Local Institution, Guadalajara, Jalisco 44280, Mexico

Local Institution, Santiago, Metropolitana 8380418, Chile

Local Institution, Santiago, Metropolitana, Chile

Suny Upstate Medical University, Syracuse, New York 13210, United States

Local Institution, Recife, Pernambuco 50070, Brazil

Local Institution, Porto Alegre, Rio Grande Do Sul 90020, Brazil

Local Institution, Porto Alegre, Rio Grande Do Sul 90035, Brazil

Local Institution, Ribeirao Preto, Sao Paulo 14049, Brazil

Local Institution, Birmingham, West Midlands B9 5ST, United Kingdom

Local Institution, Parrow Valley, Western Cape 7505, South Africa

Local Institution, Merida, Yucatan 97000, Mexico

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: May 2011
Last updated: August 4, 2015

Page last updated: August 23, 2015

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