AEGiS-13IAC: ABT-378/Ritonavir in HIV-infected children.

13th International AIDS Conference


Durban, South Africa - July 9-July 14, 2000

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ABT-378/Ritonavir in HIV-infected children.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. MoOrB177)

Violari A, Saez - Llorens X, Bernstein B, Xu Y, Deetz C, Gomez P, Handelsman E, Pelton S, Cahn P
A. Violari, Chris Hani Bargwanath Hospital POBox 2013, Johannesburg, South Africa, Tel.: +271 193 839 84, Fax: +271 193 839 73, E-mail: phru@pixie.co.za

BACKGROUND: ABT-378/r has demonstrated activity in adult antiretroviral naive (96% >50 c/ml on treatment at 72 Weeks) and protease inhibitor (PI) experienced subjects (76% >50 c/ml on treatment at Week 48).

METHODS: M98-940 is a Phase I/II, open-label study of coformulated ABT-378/r (liquid) in 100 HIV-infected antiretroviral naive and experienced but non-nucleoside reverse transcriptase inhibitor naive pediatric subjects (6 months to 12 years old). Subjects were randomized to the protease inhibitor ABT-378/r (230/57.5 mg/m2 BID or 300/75 mg/m2 BID) with naive subjects receiving d4T and 3TC and experienced subjects receiving nevirapine and 1-2 nucleoside reverse transcriptase inhibitors (NRTIs).

RESULTS: (on treatment) BL Demographics: Naive NRTI Experienced NRTI + PI Experienced (44) (32) (24) Median Age (range) 4 (6 mo-10 yrs) 5 (8 mo-11 yrs) 6 (20 mo-12 yrs) Median CD4 674 cells/mm3 751 cells/mm3 583 cells/mm3 Median Viral Load 5.1 log10 c/ml 4.3 log10 c/ml 4.8 log10 c/ml >400 c/ml at Week 16 79% (34/43) 77% (24/31) 57% (12/21) Week 16 CD4 rise 203 cells/mm3 155 cells/mm3 194 cells/mm3

CONCLUSIONS: To date no significant difference in efficacy or safety/tolerability was detected between the two ABT-378/r doses and no age effect was identified. Also to date no subjects have discontinued the study for ABT-378/r related adverse events. Liquid ABT-378/r at a dose of 300/75 mg/m2 approximates the plasma levels achieved in adults taking ABT-378/r 400/100 mg capsules.

Keywords: AEGIS, Ritonavir, Pyrimidinones, HIV Infections, Reverse Transcriptase Inhibitors, Viral Load, Nevirapine, Stavudine, Lamivudine, HIV Seropositivity, lopinavir, Child, Human, AdultKWDaegis,ritonavir,pyrimidinones,hivinfections,reversetranscriptaseinhibitors,viralload,nevirapine,stavudine,lamivudine,hivseropositivity,lopinavir,child,human,adult
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MoOrB177

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