Abstract 980 Poster Session IV, Tuesday, 5/4 (poster 102)

Analysis is presented for 19 therapy-experienced, HIV-infected children started on combination antiretroviral regimens including nelfinavir [NLV] between May and December 1997 (30 mg/kg/dose Q8h -later increased]. Mean age was 8.37 years (range 1.1 to 13.8 years). 17/19 were CDC Immunological Category 3 (advanced), 11/19 were Clinical Category C. Patients had seen a median of 4 prior antiretroviral drugs, but no prior PI therapy. NLV was combined with D4T (16), 3TC (7), ddI (8), and/or nevirapine (8). All but one patient received at least one new RT inhibitor. Antiretroviral regimens included 4 drugs (2 patients), 3 drugs (16 patients), and 2 drugs (1 patient). (Table)

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One child died at week 8. Two had medications stopped due to non-adherence, two transferred to other centers. One patient had medicine stopped due to laboratory failure and family stress. Conclusion: Through 48 weeks, the patients on NLV-containing therapeutic regimens still had positive CD4+ response, although viral RNA concentrations were close to baseline. The positive appearing "disconnection" between viral failure and immunological success can last at least 48 weeks.

Partially Funded by the NIH Pediatric AIDS Clinical Trials Group