Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV

Summary

The purpose of this study is to determine the effect of increased doses of lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing their current antiretroviral regimen

Timeline

Start

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Primary completion

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Completion

2006-12

Publications

• Background Foster C, Lyall EG. Children with HIV: improved mortality and morbidity with combination antiretroviral therapy. Curr Opin Infect Dis. 2005 Jun;18(3):253-9. doi: 10.1097/01.qco.0000168387.24142.cf.
• Background Havlir DV, Gilbert PB, Bennett K, Collier AC, Hirsch MS, Tebas P, Adams EM, Wheat LJ, Goodwin D, Schnittman S, Holohan MK, Richman DD; ACTG 5025 Study Group. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS. 2001 Jul 27;15(11):1379-88. doi: 10.1097/00002030-200107270-00007.
• Background Kempf DJ, Isaacson JD, King MS, Brun SC, Sylte J, Richards B, Bernstein B, Rode R, Sun E. Analysis of the virological response with respect to baseline viral phenotype and genotype in protease inhibitor-experienced HIV-1-infected patients receiving lopinavir/ritonavir therapy. Antivir Ther. 2002 Sep;7(3):165-74.
• Background Kulkosky J, Nunnari G, Otero M, Calarota S, Dornadula G, Zhang H, Malin A, Sullivan J, Xu Y, DeSimone J, Babinchak T, Stern J, Cavert W, Haase A, Pomerantz RJ. Intensification and stimulation therapy for human immunodeficiency virus type 1 reservoirs in infected persons receiving virally suppressive highly active antiretroviral therapy. J Infect Dis. 2002 Nov 15;186(10):1403-11. doi: 10.1086/344357. Epub 2002 Oct 29.
• Results Malee K, Williams PL, Montepiedra G, Nichols S, Sirois PA, Storm D, Farley J, Kammerer B; PACTG 219C Team. The role of cognitive functioning in medication adherence of children and adolescents with HIV infection. J Pediatr Psychol. 2009 Mar;34(2):164-75. doi: 10.1093/jpepsy/jsn068. Epub 2008 Jul 22.
• Results Robbins BL, Capparelli EV, Chadwick EG, Yogev R, Serchuck L, Worrell C, Smith ME, Alvero C, Fenton T, Heckman B, Pelton SI, Aldrovandi G, Borkowsky W, Rodman J, Havens PL; PACTG 1038 Team. Pharmacokinetics of high-dose lopinavir-ritonavir with and without saquinavir or nonnucleoside reverse transcriptase inhibitors in human immunodeficiency virus-infected pediatric and adolescent patients previously treated with protease inhibitors. Antimicrob Agents Chemother. 2008 Sep;52(9):3276-83. doi: 10.1128/AAC.00224-08. Epub 2008 Jul 14.

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