Medical Advocates for Social Justice
Conference Poster

5th International Congress on Drug Therapy in HIV Infection
Glasgow, Scotland, October 22-26, 2000

ABT-378/Ritonavir (ABT-378/r) in HIV Infected Children

P. CAHN, C. RENZ, C. DEETZ, Y. XU, X. SAEZ-LLORENS, A. VIOLARI, P. GOMEZ, E. HANDELSMAN, S. PELTON, O. RAMILO, E. CHADWICK, S. ARPADI, U. ALLEN1, R. BERTZ & E. SUN



 

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M98-940 is a Phase I/II, open-label study of coformulated ABT-378/r (liquid) in 100 HIV-infected ARV naive and experienced (exp) but NNRTI naive pediatric (6mo-12yrs) subjects. Subjects were randomized to 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 NRTIs. Based on an analysis of safety/tolerability, antiviral activity and pharmacokinetics, all subjects were switched to 300/75 mg/m2 BID dose after Week 12.

Naive (44)

NRTI Exp (32)

NRTI+PI Exp (24)

BL Demographics

median age (range)

4 yrs (6mo-10yrs)

5 yrs (8mo-11yrs)

6 yrs (20mo-12yrs)

median CD4

674 cells/mm3

751 cells/mm3

583 cells/mm3

median VL

5.1 log10c/ml

4.3 log10c/ml

4.8 log10c/ml

Week 40 Efficacy*

<400 (ITT)

84% (37/44)

81% (26/32)

58% (14/24)

<50 (ITT)

66% (29/44)

69% (22/32)

54% (13/24)

decrease in HIV RNA from BL

2.1 log10c/mL

1.5 log10c/mL

1.4 log10c/mL

increase in CD4 from BL

314 cells/mm3

333 cells/mm3

247 cells/mm3

* The data presented will be updated with Week 48 results.

No statistically significant difference in antiviral activity was noted for subjects <2 years old or >2 years old. Two subjects have discontinued from the study at Week 40. One of these discontinuations was as a result of an ABT-378/r related AE. The most commonly reported AE of at least moderate severity and probable, possible or unknown relationship to ABT-378/r was rash (2%). Based on the pediatric grade criteria used by the PACTG, no Grade 3 or higher elevations in triglycerides or cholesterol were observed. Only one Grade 2 elevation in triglyceride (976 mg/dL) was observed.

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Abstract:  ABT-378/Ritonavir (ABT-378/r) in HIV Infected Children

© 2000 Medical Advocates for Social Justice