A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)