Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients

NCT ID: NCT01335698

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-27
• Study Completion Date: 2018-01-22

Brief Summary

The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage 1: Atazanavir + Ritonavir

Participants received atazanavir powder orally (dosed by weight: 5 to \<10 kg=150 mg, 5 to \<10 kg=200 mg, 10 to \<15 kg=200 mg, 15 to \<25 kg=250 mg, 25 to \<35 kg=300 mg) once daily for 24 to 48 weeks or a weight ≥35 kg. Participants also received ritonavir once daily for 24 to 48 weeks or weight ≥35 kg in the form of 80-mg/mL solution, orally (dosed by weight 5 to \<25 kg=80 mg, 25 to \<35 kg=100 mg); 100-mg capsule, orally (dosed by weight 25 to \<35 kg=100 mg); or 100-mg tablet, orally (dosed by weight 25 to \<35 kg=100 mg)

Group Type: EXPERIMENTAL

Atazanavir Sulphate

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Interventions

Atazanavir Sulphate

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Other Intervention Names

Reyataz; BMS-232632; Norvir

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Experienced participants who received atazanavir or atazanavir/ritonavir at any time prior to study enrollment or who have a history of 2 or more protease inhibitor failures
• Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to study medications
• Cardiac rhythm abnormalities
• Need for tenofovir
• Weight <5 or ≥35kg
• >Grade 2 abnormality in aspartate transaminase/alanine transaminase levels
• Coinfection with either hepatitis B or C virus
• Any active Centers for Disease Control and Prevention Category C clinical condition

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Children'S National Medical Center

Washington D.C., District of Columbia, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Local Institution

Buenos Aires, Bs As, Buenos Aires, Argentina

Local Institution

Bunos Aires, Buenos Aires, Argentina

Local Institution

Recife, Pernambuco, Brazil

Local Institution

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution

Ribeirão Preto, São Paulo, Brazil

Local Institution

Santiago, Santiago Metropolitan, Chile

Local Institution

Santiago, Santiago Metropolitan, Chile

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Df, Mexico City, Mexico

Local Institution

Mérida, Yucatán, Mexico

Local Institution

Oaxaca City, , Mexico

Local Institution

Puebla City, , Mexico

Local Institution

Warsaw, , Poland

Local Institution

Bucharest, , Romania

Local Institution

Saint Petersburg, , Russia

Local Institution

Saint Petersburg, , Russia

Local Institution

Smolensk, , Russia

Local Institution

Port Elizabeth, Eastern Cape, South Africa

Local Institution

Port Elizabeth, Eastern Cape, South Africa

Local Institution

Bloemfontein, Free State, South Africa

Local Institution

Benoni, Gauteng, South Africa

Local Institution

Coronationville, Gauteng, South Africa

Local Institution

Pretoria, Gauteng, South Africa

Local Institution

Soweto, Gauteng, South Africa

Local Institution

Parrow Valley, Western Cape, South Africa

Local Institution

Barcelona, , Spain

Local Institution

Madrid, , Spain

Local Institution

Birmingham, WEST Midlands, United Kingdom

Countries

United States; Argentina; Brazil; Chile; Mexico; Poland; Romania; Russia; South Africa; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

2010-024537-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AI424-451

Identifier Type: -

Identifier Source: org_study_id