None listed
Conditions
Interventions
Patients weighing 5 to
25kg transitioned from the powder to the capsule formulation of ATV. Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg
those who weighed 20 to <40 kg received ATV, 200 mg, and RTV, 100 mg
Patients weighing 15 to
25kg transitioned from powder to
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Sex/Gender
All
Age
3 Years to 72 Years
Inclusion criteria
Inclusion criteria: • Confirmed human immunodeficiency virus (HIV)-1 infection diagnosed by a positive virologic test result on 2 separate occasions by: HIV DNA polymerase chain reaction, HIV RNA with values =1,000 copies/mL • Positive HIV enzyme-linked immunosorbent assay at =18 months of age, with confirmatory Western blot or indirect immunoflourescence antibody • Infants and children of either sex, aged =3 months to 5 to <25 kg with any screening baseline plasma viral load • Screening plasma viral load =1,000 copies/mL by Roche Amplicor HIV RNA Assay • Documented genotypic and phenotypic sensitivity at screening to ATV (fold change in susceptibility <2.2) and to at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) approved in the infant´s country • Genotypic sensitivity at screening to atazanavir (ATV) and at least 2 NRTIs • Antiretroviral (ARV) treatment-naive or ARV treatment-experienced. Treatment-experienced participants are defined by previous exposure to ARVs through either prior treatment for HIV infection or through postnatal treatment with =1 ARV for the prevention of mother to child transmission. For the purposes of this study, participants exposed to ARVs in utero or intrapartum may be included in the study but will be considered treatment naive. ATV-naive participants must have genotypic sensitivity at screening to ATV (fold change in susceptibility <2.2) and to both components of the local NRTI backbone. The NRTIs must have been approved for pediatric use at the local country level.
Exclusion criteria
Exclusion criteria: • Experienced participants who received ATV or ATV/ritonavir (RTV) at any time prior to study enrollment or with a history of 2 or more protease inhibitor failures • ARV-naïve or -experienced HIV-1 infected patients with contraindication to study medications syncope • Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval at screening of >440 ms • One of the following cardiac rhythm abnormalities documented on screening electrocardiogram: 1st degree atrioventricular (AV) block as defined by protocol, type I 2nd degree AV block while awake, type II 2nd degree AV block at any time, complete AV block at any time, or age-adjusted heart rate Grade 2 aspartate transaminase or alanine transaminase abnormalities • Hypersensitivity to any component of the study medication formulations (ATV/RTV, or a locally prescribed NRTI with a pediatric indication) • Infants and children of either gender <3 months or =5 years and 6 months at the time of first treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Measure:Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation Timepoints:From Day 1 to Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4==1000-=750-=500-10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15. Measure:Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4 Timepoints:After Day 1 to Week 48 ; Outcome name:Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds. Measure:Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48 Timepoints:From Baseline to Week 48 ; Outcome name:CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobact | — |
Countries
Argentina, Brazil, Chile, Colombia, Italy, Mexico, Peru, Poland, Russian Federation, South Africa, Thailand, United States
Contacts
Public ContactUrsula Noto
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed