Clinical trial NCT01691794: Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
Official title: A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV, Pediatric
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.


Eligibility criteria: Inclusion Criteria:

* Confirmed HIV-1 infection diagnosed by protocol criteria
* Male or female children, ≥ 6 years to \<17 years 6 months of age at the time of first treatment
* Antiretroviral-naïve or treatment-experienced participants with a detectable viral load
* Antiretroviral-naïve participants must have genotypic sensitivity at screening to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which have been approved for pediatric use and dosed per local country label
* Antiretroviral-experienced participants must have documented genotypic and phenotypic sensitivity at screening to atazanavir (fold change in susceptibility \<2.2) and at least 2 NRTIs, which have been approved for pediatric use and dosed per local country label.

Exclusion Criteria:

* Experienced participants who received atazanavir with or without ritonavir at any time prior to study enrollment
* Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to study medications
* Documented cardiac conduction abnormality, significant cardiac dysfunction, or a history syncope
* Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval of \>440 ms at screening
* One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram:

  1. First degree atrioventricular (AV) block, as defined by protocol
  2. 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
* Coinfection with either hepatitis B or C virus

Primary outcomes:
measure: Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events
timeFrame: From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
measure: Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4
timeFrame: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
measure: Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)
timeFrame: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children'S Hospital
state: Arizona
city: Atlanta
country: United States
facility: Grady Health System Ponce Family And Youth Clinic
state: Georgia
city: Dallas
country: United States
facility: Children'S Medical Center Of Dallas
state: Texas
city: Buenos Aires, Bs As
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Local Institution
state: SP
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo LEON
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Puebla
country: Mexico
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern CAPE
city: Bloemfontein
country: South Africa
facility: Local Institution
state: FREE State
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: