PACTG 1038

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PACTG PI038 is a Phase I/II, open label study of high dose Lopinavir/Ritonavir +/- Saquinavir in HIV-infected children and adolescents who have at least six months of prior PI experience and are failing their current antiretroviral therapy (plasma HIV RNA >5000 copies/ml). The study will seek to enroll 48 subjects >2 years to < 18 years of age. Subjects will be stratified by concurrent NNRTI treatment and subjects will be treated for 48 weeks for the start of the initial LPV/v dose. The primary objectives are to determine the safety, tolerability of high dose Lopinavir/Ritonavir (and for some subjects, Saquinavir) with concurrent NNRTI treatment in children and adolescents as well as to monitor the harmacokinetic parameters for LPV/r and Saquinavir in protease inhibitor experienced HIV-infected subjects receiving combination antiretroviral regimens. PACTG 1038 seeks to offer therapeutic options for HIV positive children and adolescents who may have previously failed antiretroviral regimens and optimize therapy with protease inhibitors in those with late-stage HIV.