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 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) Revised Protocol 01, incorporating Protocol Amendment 01. - the PRINCE I study
- Conditions
- HIV pediatricMedDRA version: 9.1Level: LLTClassification code 10020161
- Registration Number
- EUCTR2009-016361-28-IT
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Signed Written Informed Consent a) Informed consent from a parent/legal guardian must be obtained prior to screening. Minors who are judged to be of an age of reason must also give their written assent (see Protocol Section 2.3). 2) Target Population Confirmed HIV-1 infection diagnosed by a positive virologic test results on 2 separate occasions by: a) HIV DNA PCR. b) HIV RNA with values = 1,000 copies/mL will be considered evidence of infection. c) Positive HIV ELISA at = 18 months of age, with confirmatory Western blot or indirect immunoflourescence antibody. Note: At least one diagnostic result may have been prior to the Screening visit. 3) Age and Sex a) Infants and children of either gender, = 3 months to < 5 years 6 months of age at the time enrollment. 4) Other Inclusion Criteria a) Screening plasma viral load = 1000 copies/mL by Roche Amplicor HIV-RNA Assay (version 1.5). b) Antiretroviral naive subjects must have genotypic sensitivity at screening to ATV and at least 2 NRTIs (excluding tenofovir). NRTIs must be approved for pediatric use at the local country level. c) Antiretroviral experienced subjects must have documented genotypic and phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and to both components of the local NRTI backbone. NRTIs must be approved for pediatric use at the local country level.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Target Disease Exceptions a) 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 will not be allowed the study. Antiretroviral-na?ve or experienced HIV-1 infected subjects with contraindication to study medications. b) Subjects with genotypic resistance at screening to ATV or either component of the local NRTI backbone based upon the following criteria: i) Any Major Mutations: I50L, I84V, N88S. ii) = 2 of the following minor or cross resistant mutations: (1) M46I/L, G48V, I54L/V/M/T/A, V82A/T/FI, L90M, V32I iii) = 3 of the following minor mutations: (1) L10I/F/V/C, L24I, L33I/F/V, F53L/Y, A71V/I/T/L, G73C/S/T/A c) The use of any investigational agent within 30 days of enrollment. d) History of psychiatric or cognitive/developmental impairment that could compromise subject safety or the ability of the subject to comply with the protocol. e) Premature infants (less than 37 weeks gestation at birth) will not be eligible to enter the study until they are over 6 months of age. f) The need for Tenofovir. 2) Medical History and Concurrent Diseases a) Any active CDC Category C clinical condition. b) Children of mothers with known maternal history of HBV or HCV infection. c) Coinfection with either HBV or HCV i) In subjects with HBV or HCV status which is unable to be determined, if the child’s mother has a history of HBV or HCV infection the child will be excluded. d) HCV ELISA positive for infants > 18 months of age. e) Documented cardiac conduction abnormality(ies) or significant cardiac dysfunction, or a history of syncope. f) Family history of QTc interval syndrome, Brugada syndrome or right ventricular dysplasia or with a corrected QTc interval at screening of > 440 ms. g) One of the following cardiac rhythm abnormalities documented on the screening ECG: First degree atrioventricular (AV) block as defined by the 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). h) History of pancreatitis, peripheral neuropathy, malignancy that requires systemic therapy, or any medical condition which, in the opinion of the investigator, adds undue risk to trial participation. i) Malabsorption syndrome. j) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. 3) Physical and Laboratory Test Findings a) Weight < 5 or = 25 kg at date of first dose (Day 1) b) > Grade 2 transaminase (AST, ALT) abnormalities. 4) Allergies and Adverse Drug Reaction a) Hypersensitivity to any component of the study medication formulations (ATV/RTV, or a locally prescribed NRTI with a pediatric indication). 5) Sex and Reproductive Status a) Infants and children of either gender, < 3 months or = 5 years and 6 months at the time of first treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method