PACTG P1038: HIGH DOSE LOPINAVIR/RITONAVIR WITH OR WITHOUT SAQUINAVIR IN HIV PTS

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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. PA CTG P1038 is a Phase I/II, open label study of high dose lopinavir/ritonavir (LPV/r) to assess the safety, tolerability, and pharmacokinetics of LPV/r with or without saquinavir (SQV) 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). This study hypothesizes that dose intensification will not only aid in overcoming resistance but in a manner analogous to cancer will result in a greater rate of inhibition and thereby maximize the degree and durability of viral suppression. Given the limited therapeutic options available to most HIV-infected children, this is an option that should be explored. 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 from the start of the initial LPV/r dose.