Phase 4
Completed N=59
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
HIV, Pediatric
Source: ClinicalTrials.gov NCT01691794 ↗
Enrolled (actual)
59
Serious AEs
13.6%
Results posted
Nov 2015
Primary outcomePrimary: 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 — 0; 0; 1; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0; 0; 1; 1; 3; 4 | — |
| PRIMARY Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 |
0; 3; 0; 0; 5; 0 | — |
| PRIMARY Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) |
0; 3; 0; 0; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed HIV-1 infection diagnosed by protocol criteria
- Male or female children, ≥ 6 years to 440 ms at screening
- One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram:
- First degree atrioventricular (AV) block, as defined by protocol
- 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
Data sourced from ClinicalTrials.gov (NCT01691794). 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.