PRINCE1
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)
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
82
6 countries
18
Study Start
October 13, 2010
Actual (reported)Primary Completion
October 4, 2012
Actual (reported)Study Completion
September 11, 2017
Actual (reported)The purpose of this study is to determine whether atazanavir powder combined with ritonavir is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to \<6 years of age.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 11, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2010
Actual (reported)April 7, 2010
Actual (reported)October 13, 2010
Actual (reported)October 4, 2012
Actual (reported)February 6, 2014
Actual (reported)September 11, 2017
Actual (reported)Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation
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.
From Day 1 to Week 48
Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
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=\<6.5. Neutrophils, absolute (/mm\^3): Gr 1=\>=1000-\<1500; Gr 2= \>=750-\<1000; Gr 3=\>=500-\<750; Gr 4=\<500. ALT/SGPT (\*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=\>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.
After Day 1 to Week 48
Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48
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.
From Baseline to Week 48
Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight
At Week 48
Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status
From Day 1 to Week 48
Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight
From Baseline to Week 48
Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status
From Baseline to Week 48
CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight
From Baseline to Week 48
Patients weighing 5 to \<10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of ≥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; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
Powder, oral, dosed by weight. Participants who weighed 5 to \<10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to \<15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to \<25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.
Local Institution
São Paulo, São Paulo, 01246-900, Brazil
Local Institution
Santiago, Santiago Metropolitan, 8380418, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Guadalajara, Jalisco, 44160, Mexico
Local Institution
Guadalajara, Jalisco, 44280, Mexico
Local Institution
Df, Mexico City, 06720, Mexico
Local Institution
Mérida, Yucatán, 97000, Mexico
Bristol-Myers Squibb
Bristol-Myers Squibb
82 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2010
First Posted
April 7, 2010
Study Start
October 13, 2010
Actual (reported)Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events
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; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss \>10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.
From Day 1 to Week 48
Patients weighing 10 to \<15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of ≥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; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
Patients weighing 15 to \<25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of ≥25kg transitioned from 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; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.
Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (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; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Local Institution
Oaxaca City, 71256, Mexico
Local Institution
Puebla City, 72000, Mexico
Local Institution
Lima, 1, Peru
Local Institution
Lima, Peru
Local Institution
Bloemfontein, Free State, 9301, South Africa
Local Institution
Coronationville, Gauteng, 2092, South Africa
Local Institution
Soweto, Gauteng, 2001, South Africa
Local Institution
KwaKhangela, KwaZulu-Natal, 4013, South Africa
Local Institution
Cape Town, Western Cape, 7505, South Africa
Local Institution
Bangkok, 10330, Thailand
Local Institution
Bangkok, 10700, Thailand
Primary Completion
October 4, 2012
Actual (reported)Study Completion
September 11, 2017
Actual (reported)Last Updated
May 24, 2018
Results First Posted
February 6, 2014
Record last verified: 2018-04
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