Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects

Study start date: December 1, 1999

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml. Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness). Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load. Will most likely respond well to the study drugs, as shown by the results of a lab test. Are at least 18 years old. Agree to use effective barrier methods of birth control (such as condoms). Are available for follow-up for at least 48 weeks. Exclusion Criteria Patients will not be eligible for this study if they: Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment. Have only recently become HIV positive. Abuse alcohol or drugs. Have severe diarrhea within 30 days of study entry. Have hemophilia. Have a history of pancreatitis. Have hepatitis within 30 days of study entry. Have peripheral neuropathy (a painful condition affecting the nervous system). Are unable to take medications by mouth. Are pregnant or breast-feeding.