TIPRANAVIR/RITONAVIR COMB W/ REVERSE TRANSCRIPTASE INHIB

Indiana Univ-Purdue Univ At Indianapolis, Indianapolis IN

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Abstract

This is a phase II, multicenter, open-label, randomized study in HIV-1 infected patients who have clinically failed multiple (two or more) protease inhibitor containing regimens. Approximately 10 study sites will be selected to enroll 30-40 patients. The study consists of two parallel groups to be treated for 24 weeks with the option of continuing study participation for an additional 24 weeks. Eligible patients 13 years of age of older with CD4 count 50 cells/mm3, HIV-1 RNA levels 5000 copies/mL of plasma, 3 months exposure to current PI therapy, and 4 months exposure to prior PI therapy will be randomized to one of two treatment arms listed below. The current PI-containing regimen must be stable for at least 2 months prior to study entry. Patients must have one new nucleoside reverse transcriptase inhibitor plus one new non-nucleoside reverse transcriptase inhibitor option available at the time of randomization. Safety and efficacy parameters will be evaluated at Week 2, 4, 8, 12, 16, 20, and 24. Treatment arms: Group A: 20 patients, Tipranavir (1200mg BID), Ritonavir (100mg BID), 1 new NRTI + 1 new NNRTI. Group B: 20 patients, Tipranavir (2400 mg BID), Ritonavir (200mg BID), 1 new NRTI + 1 new NNRTI. FDA approved nucleoside analogue options: Abacavir, Didanosine, Lamivudine, Stavudine, Zalcitabine, Zidovudine FDA approved non-nucleoside analogue options: Efavirenz, Nevirapine