|
|
Share this Abstract with a Colleague
Background: Long-term follow-up of Kaletra (lopinavir/ritonavir, formerly known as ABT-378/r) suspension at a dose of 300/75 mg/m2BID in HIV-infected children.
Methods: 100 antiretroviral (ARV)-naive and -experienced (exp.) but NNRTI-naïve pediatric subjects ages 6 months to 12 years old were randomized to Kaletra, with naive subjects receiving d4T and 3TC and exp. subjects receiving nevirapine and 1—2 NRTIs.
Results: Three groups of subjects with varying ARV treatment experience were analyzed: 44 naïve (I), 32 NRTI exp. (II) and 24 NRTI + PI exp. (III). Mean % CD4 increase from baseline (and mean % CD4 at Week 48) was 10.3 (21.6) for I, 5.3 (28.6) for II and 6.7 (23.2) for III. By an intent-to-treat analysis, HIV RNA % <400 (and <50) copies/mL were 84 (71) for I, 88 (69) for II and 58 (54) for III at Week 48. Of the two discontinuations prior to Week 48, one (due to pancreatitis) appeared to be related to study drug. The most commonly reported AE of at least moderate severity and probable or possible relationship to Kaletra was rash (2%). No Grade 3 or higher elevations in glucose, triglyceride or cholesterol were observed (NIH Division of AIDS Toxicity Grades). Virologic response with respect to baseline protease genotype and phenotype was similar to that observed in adults. Baseline resistance data was available for 20 of 24 subjects in Group III. Of these, 1 of 3 subjects with >10-fold and 10 of 17 subjects with <10 fold reduced susceptibility (by phenotypic assay) to Kaletra had HIV RNA <400 copies/mL. Results will be updated.
Conclusions: Based on ongoing study results, Kaletra suspension appears to be well-tolerated and associated with antiviral activity in HIV-infected children.
Authors
1 Hosp. del Nino, Panama City, Panama, 2 Fundacion Huesped, Buenos Aires, Argentina, 3 Baragwanath Hosp., Johannesburg, South Africa, 4 Princess Margaret, Nassau, Bahamas, 5 Univ. Hosp. of Brooklyn, Brooklyn, NY, 6 Maxwell Finland Lab, Boston, MA, 7 Univ. of Texas Southwestern Med. Ctr., Dallas, TX, 8 Children’s Mem. Hosp., Chicago, IL, 9 St. Luke’s Roosevelt Hosp. Ctr., NYC, NY, 10 Hosp. for Sick Children, Toronto, Ontario, and 11 Abbott Laboratories Poster
© 2001 Medical Advocates
for Social Justice
225 West Washington Street, Suite 2200, Chicago, IL 60606
Telephone (312) 419-7289 Facsimile: (312) 419-7151
Email: [email protected]
