Phase 3
Completed N=99
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
Source: ClinicalTrials.gov NCT01335698 ↗Enrolled (actual)
99
Serious AEs
27.3%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder |
0; 0; 0; 0; 0; 3 | — |
| PRIMARY Number of Participants Who Experienced a SAE on ATV Powder |
6; 3; 8; 8; 0 | — |
| PRIMARY Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder |
2; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder |
0; 0; 4; 6; 0; 4 | — |
| SECONDARY Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort |
10; 2; 10; 19; 5; 15 | — |
| SECONDARY Mean Change From Baseline in HIV RNA on ATV Powder |
-2.10; -3.07; -2.69; -2.66; -2.24; -2.31 | — |
| SECONDARY Mean Change From Baseline in CD4 Percent on ATV Powder |
5.1; 4.0; 5.4; 6.3; -0.3; 2.8 | — |
| SECONDARY CD4 Cell Count Changes From Baseline on ATV Powder |
218.7; 67.8; 247.1; 246.1; 145.8; -409.8 | — |
| SECONDARY Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 |
4; 0; 4; 3; 0; 1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
5776.70; 5644.12; 4893.75 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) |
718.90; 857.06; 1030.64 | — |
| SECONDARY Area Under the Concentration-Time Curve [AUC(TAU)] |
49387.12; 59671.80; 56356.00 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria
- Confirmed HIV-1 infection diagnosed by protocol criteria
- Screening HIV RNA level ≥1000 copies/mL
- ≥3 months to Grade 2 abnormality in aspartate transaminase/alanine transaminase levels
- Coinfection with either hepatitis B or C virus
- Any active Centers for Disease Control and Prevention Category C clinical condition
Data sourced from ClinicalTrials.gov (NCT01335698). 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.