Tipranavir/Ritonavir (500/200 mg and 500/100 mg) Was Virologically Non-Inferior to Lopinavir/Ritonavir (400/100 mg) at Week 48 in Treatment-Naïve HIV-1-Infected Patients: A Randomized, Multinational, Multicenter Trial
| Autor: | Patrick A. Robinson, Damien V. Cordery, Frank Bergmann, Joseph Scherer, Roberto Zajdenverg, José L. de Andrade Neto, Keikawus Arastéh, David A. Cooper, Kiat Ruxrungtham, Ricardo L. Chaves, study team |
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| Rok vydání: | 2016 |
| Předmět: |
Male
0301 basic medicine Gastrointestinal Diseases Pyridines lcsh:Medicine Lopinavir/ritonavir HIV Infections Pharmacology Gastroenterology Lopinavir law.invention 0302 clinical medicine Randomized controlled trial law Antiretroviral Therapy Highly Active 030212 general & internal medicine lcsh:Science Sulfonamides Multidisciplinary Lamivudine Middle Aged Disease Progression Drug Therapy Combination Female Chemical and Drug Induced Liver Injury Tipranavir Research Article medicine.drug Adult medicine.medical_specialty Adolescent Anti-HIV Agents 030106 microbiology Drug Administration Schedule Young Adult 03 medical and health sciences Internal medicine Multicenter trial Drug Resistance Viral medicine Humans Tenofovir Aged Proportional Hazards Models Ritonavir business.industry lcsh:R HIV Protease Inhibitors CD4 Lymphocyte Count Regimen Pyrones HIV-1 lcsh:Q business |
| Zdroj: | PLoS ONE, Vol 11, Iss 1, p e0144917 (2016) PLoS ONE |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0144917 |
| Popis: | Ritonavir-boosted tipranavir (TPV/r) was evaluated as initial therapy in treatment-naïve HIV-1-infected patients because of its potency, unique resistance profile, and high genetic barrier. Trial 1182.33, an open-label, randomized trial, compared two TPV/r dose combinations versus ritonavir-boosted lopinavir (LPV/r). Eligible adults, who had no prior antiretroviral therapy were randomized to twice daily (BID) 500/100 mg TPV/r, 500/200 mg TPV/r, or 400/100 mg LPV/r. Each treatment group also received Tenofovir 300 mg + Lamivudine 300 mg QD. The primary endpoint was a confirmed viral load (VL) 65% of patients receiving either TPV/r200 or TPV/r100. The trial was subsequently discontinued; primary objectives were achieved and continuing TPV/r100 was less tolerable than standard of care for initial highly active antiretroviral therapy. All treatment groups had similar 48-week treatment responses. TPV/r100 and TPV/r200 regimens resulted in sustained treatment responses, which were non-inferior to LPV/r at 48 weeks. When compared with the LPV/r regimen and examined in the light of more current regimens, these TPV/r regimens do not appear to be the best options for treatment-naïve patients based on their safety profiles. |
| Databáze: | OpenAIRE |
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