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A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines
Treatment of children and infants with HIV requires modification of medication dosing according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line treatment option that is increasingly necessary due to infant drug resistance, this dosing is often complicated and impractical in busy clinical settings. To address this, the World Health Organization (WHO) has released a simplified dosing table based on infant weight bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants when dosed according to the new WHO guidelines.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 97 |
| Start date | 2010-11 |
| Completion | 2013-12 |
Conditions
- HIV
Interventions
- Lopinavir/ritonavir
Primary outcomes
- Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24) — Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose
Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir - Maximum Concentration of Lopinavir/Ritonavir (Cmax) — Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose
Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling - Minimum Concentration of Lopinavir/Ritonavir (Cmin) — Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose
Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling - Clearance of Lopinavir/Ritonavir (CL/F) — Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose
Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling - Proportion of Participants With an AUC of Less Than 10% of Adults — Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose
Proportion of participants with an AUC less that 10% of adults (AUC0-24 \<104 mcg\*hr/mL) - Number of Participants Experiencing Adverse Events of Grade 3 or 4 — Measured at study visits through end of study (weeks 2, 4, 12, 24)
Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death
Countries
United States, Brazil, South Africa, Thailand