Abbott Seeks Pediatric Indication For Norvir

Data from an ongoing Phase I/II clinical trial with AbbottLaboratories' Norvir (ritonavir) have been presented to the US Food and Drug Administration. The company is seeking a label recommendation for the use of Norvir in the treatment of children with HIV and AIDS.

44 patients received an oral liquid formulation of Norvir, at doses ranging between 250mg/m2 and 400mg/m2, twice a day for 12 weeks.

After eight weeks of monotherapy, children saw a mean CD4 increase of 51 cells/mm3 to 132 cells/mm3. Viral load decreased by over 90% and remained below baseline after 24 weeks. Diarrhea, vomiting and abdominal pain were the most frequently-reported adverse events.