Pilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1 PI-Based Regimen

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dc.contributor.authorCahn, Pedro
dc.contributor.authorMontaner, Julio
dc.contributor.authorJunod, Patrice
dc.contributor.authorPatterson, Patricia
dc.contributor.authorKrolewiecki, Alejandro J.
dc.contributor.authorAndrade-Villanueva, Jaime
dc.contributor.authorCassetti, Isabel
dc.contributor.authorSierra Madero, Juan
dc.contributor.authorCasiro, A. D.
dc.contributor.authorBortolozzi, Raul
dc.contributor.authorLupo, Silvana H.
dc.contributor.authorLongo, Nancy
dc.contributor.authorRampakakis, Emmanouil
dc.contributor.authorAckad, Nadia
dc.contributor.authorSampalis, John S.
dc.date.accessioned2024-05-23T18:53:33Z
dc.date.available2024-05-23T18:53:33Z
dc.date.issued2011
dc.description.abstractObjectives 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<200copies/mL (Pā€Š=ā€Š0.61). Time-to-virologic rebound, changes in PROs, CD4+ T-cell-count and VL from baseline, also exhibited no statistically-significant between-group differences. Most frequent AEs were diarrhea (19%), headache (18%) and influenza (16%). Four (10%) patients on LPV/r were intensified with 2 NRTIs, all regaining virologic control. Eight serious AEs were reported by 5(2:LPV/r;3:HAART) patients. Conclusion At day-360, virologic efficacy and safety of LPV/r appears comparable to that of a PI+2NRTIs HAART. These results suggest that our individualized, simplified maintenance strategy with LPV/r-monotherapy and protocol-mandated NRTI re-introduction upon viral rebound, in virologically-suppressed patients merits further prospective long-term evaluation.
dc.identifier.citationCahn, P., Montaner, J., Junod, P., Patterson, P., Krolewiecki, A. J., ... Sampalis, J. S. (2011). Pilot, randomized study assessing safety, tolerability and efficacy of simplified LPV/r maintenance therapy in HIV patients on the 1st PI-based regimen. PLoS ONE.
dc.identifier.otherDOI: 10.1371/journal.pone.0023726
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1095
dc.relation.ispartofseriesPLoS ONE
dc.subjectPilot Study
dc.subjectLPV/r Maintenance Therapy
dc.subjectHIV Patients
dc.subjectPI-Based Regimen
dc.titlePilot, Randomized Study Assessing Safety, Tolerability and Efficacy of Simplified LPV/r Maintenance Therapy in HIV Patients on the 1 PI-Based Regimen

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