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Open-Label Study of a Twice-Daily Indinavir 800-mg/Ritonavir 200-mg Regimen in HIV-Infected Adults Failing a Protease Inhibitor Regimen

2002; Lippincott Williams & Wilkins; Volume: 31; Issue: 5 Linguagem: Inglês

10.1097/00126334-200212150-00005

1944-7884

Harold Katner, Dávid Paár, Jeffrey P. Nadler, Erin Jensen, Helene M. Wilson, Tyler S. Finn, Richard A. Petruschke, Robert K. Zeldin,

HIV/AIDS Research and Interventions

Summary: There is no standard treatment of HIV-infected patients who fail protease inhibitor (PI)-containing antiretroviral therapy. This open-label, noncomparative 24week study with a 24-week extension evaluated the efficacy, safety, and tolerability of twice-daily indinavir/ritonavir 800/200 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) in this population. Presented here are the results of the 24-week study. Patients were HIV-infected adults who had prior viral RNA (vRNA) suppression (<400 copies/mL), subsequent failure (≥400 and ≤100,000 copies/mL) on antiretroviral therapy, and at least one new NRTI available for treatment. The proportions of patients achieving plasma vRNA <400 and <50 copies/mL were analyzed with data as observed (DAO) and intention-to-treat (ITT) models using generalized estimating equations (GEE) or counting noncompleters as failures (NC = F). Mean changes from baseline in vRNA and CD4 cell count were evaluated using DAO and an ITT mixedmodel approach. Sixty-three patients (87% male) with a mean age of 42 years and mean baseline vRNA and CD4 cell counts of 3.8 log10 copies/mL and 360 cells/mm3, respectively, were enrolled. The proportion (95% confidence interval) of patients achieving vRNA <400 and 1.0 log10 copies/mL and CD4 cell counts increased by approximately 90 cells/mm3. Three patients (5%) experienced serious drug-related adverse events. Seven patients (11%) discontinued treatment due to clinical or laboratory adverse events. In this study, the enhanced, twice-daily regimen of indinavir/ritonavir 800/200 mg plus 2 NRTIs provided suppression of HIV in many patients who had failed a PI-containing regimen and was generally well tolerated.