Abstract 957 Poster Session IV, Tuesday, 5/4 (poster 101)

There is limited information on the pharmacodynamic relationship of antiretroviral agents to HIV-1 viral load response in children receiving HAART. Intensive NFV pharmacokinetics (PK) was performed 4 weeks after randomization to 3 of 4 protocol treatment arms containing NFV in antiretroviral experienced children aged ≥4 months to 17 years enrolled in PACTG 377. Association of the NFV PK with HIV-1 RNA response at weeks 4, 8, and 12 was evaluated in these children. NFV concentrations were determined using a validated HPLC assay and PK parameters estimated using noncompartmental methods. Suppression of HIV replication was monitored by quantitative HIV-1 RNA PCR measurement (Roche Amplicor). Responses were assessed in 38 children receiving NFV with PK data available, including 7 receiving NFV BID. NFV AUC or Cmin (typically obtained 10-15 hours following TID dosing) were correlated with % of children with virologic success, undetectable HIV-1 RNA (<400 copies) at week 12 or a change in RNA from baseline to week 12.

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