Ritonavir-Boosted Tipranavir Demonstrates Superior Efficacy to Ritonavir-Boosted Protease Inhibitors in Treatment-Experienced HIV-Infected Patients: 24-Week Results of the RESIST-2 Trial
| dc.contributor.author | Cahn, Pedro | |
| dc.contributor.author | Villacian, Jorge | |
| dc.contributor.author | Lazzarin, Adriano | |
| dc.contributor.author | Katlama, Christine | |
| dc.contributor.author | Grinsztejn, Beatriz | |
| dc.contributor.author | Arasteh, Keikawus | |
| dc.contributor.author | López, Paulo | |
| dc.contributor.author | Clumeck, Nathan | |
| dc.contributor.author | Gerstoft, Jan | |
| dc.contributor.author | Stavrianeas, Nikolas | |
| dc.contributor.author | Moreno, Santiago | |
| dc.contributor.author | Antunes, Francisco | |
| dc.contributor.author | Neubacher, Dietmar | |
| dc.contributor.author | Mayers, Douglas | |
| dc.date.accessioned | 2024-05-23T23:49:01Z | |
| dc.date.available | 2024-05-23T23:49:01Z | |
| dc.date.issued | 2006-11-15 | |
| dc.description | Fil: Cahn P. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description.abstract | Background. Tipranavir, a novel protease inhibitor, has demonstrated antiviral activity against protease inhibitor—resistant human immunodeficiency virus type 1 (HIV-1) isolates. The Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST-2) trial is an ongoing, open-label, phase III trial comparing ritonavir-boosted tipranavir (TPV/r) plus an optimized background regimen with an individually optimized, ritonavir-boosted protease inhibitor in treatment-experienced, HIV-1-infected patients. Methods. Patients at 171 sites in Europe and Latin America who had received ⩾2 previous protease inhibitor regimens, had triple-antiretroviral class experience, had an HIV-1 RNA level ⩾1000 copies/mL, and had genotypically demonstrated primary protease inhibitor resistance were eligible. After genotypic resistance tests were performed, a protease inhibitor and optimized background regimen were selected before randomization. Patients were randomized to receive either TPV/r or comparator protease inhibitor—ritonavir (CPI/r) and were stratified on the basis of preselected protease inhibitor and enfuvirtide use. Treatment response was defined as a confirmed HIV-1 load reduction ⩾1 log10 less than the baseline value without a treatment change at week 24. Results. A total of 863 patients were randomized and treated. At baseline, the mean HIV-1 load was 4.73 log10 copies/mL, and the mean CD4+ cell count was 218 cells/mm3. The preplanned 24-week efficacy analyses of 539 patients demonstrated treatment response rates of 41% in the TPV/r arm and 14.9% in the CPI/r arm (intent-to-treat analysis; P < .0001). The mean CD4+ cell count increased by 51 cells/mm3 in the TPV/r arm and by 18 cells/mm3 in the CPI/r arm. The most common adverse events were mild-to-moderate diarrhea, nausea, and headache. Grade 3 or greater elevations in serum transaminase, cholesterol, and triglyceride levels were more frequent in the TPV/r arm. Conclusions. TPV/r had superior antiviral activity and increased immunologic benefits, compared with CPI/r, at week 24 among treatment-experienced patients infected with multidrug-resistant HIV-1. | es_ES |
| dc.format | application/pdf | es_ES |
| dc.identifier.doi | https://doi.org/10.1086/508352 | |
| dc.identifier.uri | https://repositorio.huesped.org.ar/handle/123456789/1299 | |
| dc.language | ENG | es_ES |
| dc.provenance | Published | es_ES |
| dc.relation.ispartofseries | Clinical Infectious Diseases;2006 Nov 15;43(10):1347-56 | |
| dc.rights | openAccess | es_ES |
| dc.subject | HIV | es_ES |
| dc.subject | Antiviral Agents | es_ES |
| dc.subject | Latin America | es_ES |
| dc.title | Ritonavir-Boosted Tipranavir Demonstrates Superior Efficacy to Ritonavir-Boosted Protease Inhibitors in Treatment-Experienced HIV-Infected Patients: 24-Week Results of the RESIST-2 Trial | es_ES |
| dc.type | Articulo | es_ES |