Pilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1st PI-Based Regimen
| Autor: | Sergio Lupo, Nadia Longo, Jaime Andrade-Villanueva, Patrice Junod, Patricia Patterson, Alejandro J. Krolewiecki, Julio S. G. Montaner, Pedro Cahn, John S. Sampalis, Emmanouil Rampakakis, Nabil Ackad, Isabel Cassetti, Arnaldo Casiro, Raul Bortolozzi, Juan Sierra-Madero |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Male
Oncology lcsh:Medicine HIV Infections Pilot Projects Pharmacology Lopinavir law.invention Maintenance therapy Randomized controlled trial immune system diseases law Antiretroviral Therapy Highly Active HIV Protease Inhibitor Precision Medicine lcsh:Science Immune Response Multidisciplinary Clinical Pharmacology virus diseases HIV diagnosis and management Middle Aged Viral Load Antivirals AIDS Treatment Outcome Reverse Transcriptase Inhibitors Medicine Infectious diseases Female Research Article medicine.drug Adult Drugs and Devices medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Anti-HIV Agents Clinical Research Design Sexually Transmitted Diseases Viral diseases Microbiology Young Adult Adverse Reactions Virology Internal medicine medicine Humans Clinical Trials Protease inhibitor (pharmacology) Adverse effect Biology Aged Ritonavir business.industry lcsh:R HIV HIV Protease Inhibitors Regimen lcsh:Q Clinical Immunology business Viral Transmission and Infection |
| Zdroj: | PLoS ONE PLoS ONE, Vol 6, Iss 8, p e23726 (2011) |
| ISSN: | 1932-6203 |
| Popis: | Objectives To compare the efficacy and safety of an individualized treatment-simplification strategy consisting of switching from a highly-active anti-retroviral treatment (HAART) with a ritonavir-boosted protease inhibitor (PI/r) and 2 nucleoside reverse-transcriptase inhibitors (NRTIs) to lopinavir/ritonavir (LPV/r) monotherapy, with intensification by 2 NRTIs if necessary, to that of continuing their HAART. Methods This is a one-year, randomized, open-label, multi-center study in virologically-suppressed HIV-1-infected adults on their first PI/r-containing treatment, randomized to either LPV/r-monotherapy or continue their current treatment. Treatment efficacy was determined by plasma HIV-1 RNA viral load (VL), time-to-virologic rebound, patient-reported outcomes (PROs) and CD4+T-cell-count changes. Safety was assessed with the incidence of treatment-emergent adverse events (AE). Results Forty-one patients were randomized to LPV/r and 39 to continue their HAART. No statistically-significant differences between the two study groups in demographics and baseline characteristics were observed. At day-360, 71(39:LPV/r;32:HAART) patients completed treatment, while 9(2:LPV/r;7:HAART) discontinued. In a Last Observation Carried Forward Intent-to-Treat analysis, 40(98%) patients on LPV/r and 37(95%) on HAART had VL |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|