Phase 3
Completed N=56
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
Source: ClinicalTrials.gov NCT01099579 ↗Enrolled (actual)
56
Serious AEs
30.4%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation — 0; 0; 0; 5 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation |
0; 0; 0; 5; 2; 4 | — |
| PRIMARY Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4 |
2; 3; 0; 3; 2; 0 | — |
| PRIMARY Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48 |
4.9; 12.0; 6.2; 1.7; -3.2; -4.2 | — |
| PRIMARY Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events |
1; 1; 0 | — |
| SECONDARY Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight |
47.6; 68.4; 71.4; 66.7; 73.7; 85.7 | — |
| SECONDARY Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status |
56.3; 68.2; 65.6; 86.4 | — |
| SECONDARY Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight |
-2.61; -2.93; -2.40 | — |
| SECONDARY Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status |
-2.53; -2.81 | — |
| SECONDARY CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight |
550.1; 225.3; 373.8 | — |
| SECONDARY CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status |
437.9; 352.1 | — |
| SECONDARY Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight |
6.1; 7.3; 8.8 | — |
| SECONDARY Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status |
4.3; 9.8 | — |
| SECONDARY Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir |
0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir |
4131; 5197; 6172; 336; 572; 698 | — |
| SECONDARY Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir |
32503; 50305; 61485; 17439; 20510; 13640 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir |
1.58; 1.97; 4.0; 1.8; 2.9; 4.0 | — |
| SECONDARY Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir |
4.61; 3.98; 4.07; 4.59; 3.90; 5.87 | — |
| SECONDARY Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir |
0.65; 0.32; 0.24; 0.65; 0.32; 0.35 | — |
Eligibility Criteria
Key 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 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.
Data sourced from ClinicalTrials.gov (NCT01099579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.