PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV) (PRINCE1)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01099579

First received: April 6, 2010

Last updated: March 28, 2013

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 6, 2010

Last Updated Date

March 28, 2013

Start Date ^ICMJE

November 2010

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The frequency and severity of adverse events, serious adverse events (clinical and laboratory) and discontinuations from study due to adverse events [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01099579 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evidence of Viral Load confirmed by HIV-RNA testing [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)

Official Title ^ICMJE

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 HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I Study)

Brief Summary

The purpose of this study is to see if atazanavir powder combined with ritonavir are safe and well-tolerated and produced appropriate drug exposure in children ≥ 3 months to < 6 years of age.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Atazanavir
Powder, Oral, Dosed by weight (5-10 kg = 150 mg, 10-15 kg = 200 mg, 15-20 kg = 250 mg), Once per day, 48 weeks or until a local pediatric ATV approval
Other Names:
- Reyataz
- BMS-232632
Drug: Ritonavir
Oral Solution, Oral, 80 mg/mL, Once per day, 48 weeks or until a local pediatric ATV approval

Other Name: Norvir

Study Arm (s)

Experimental: Atazanavir + Ritonavir

Interventions:

Drug: Atazanavir
Drug: Ritonavir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2017

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV 1 infection diagnosed by protocol criteria
≥ 3 months to < 5 years and 6 months of age at time of first treatment, and weight > 5 to < 25kg with any screening baseline plasma viral load
antiretroviral naive and experienced
Screening HIV RNA ≥ 1000 copies/mL
Must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country. (naives only require a genotpye)
Subjects must have documented genotypic and 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 PI failures
Antiretroviral-naïve or experienced HIV-1 infected patients with contraindication to study medications syncope
Family history of QTc interval syndrome, Brugada syndrome or right ventricular dysplasia or with a corrected QTc interval at screening of > 440 ms
One of the following cardiac rhythm abnormalities documented on the screening ECG: First degree atrioventricular (AV) block as defined by protocol
Type I second degree AV block while awake, type II second degree AV block at any time, complete AV block at any time, or age-adjusted heart rate < 2nd percentile)
Use of Tenofovir

Gender

Both

Ages

3 Months to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Chile, Colombia, Italy, Mexico, Peru, South Africa, Thailand

Administrative Information

NCT Number ^ICMJE

NCT01099579

Other Study ID Numbers ^ICMJE

AI424-397, 2009-016361-28

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top