title: Pilot, randomized study assessing safety, tolerability and efficacy of simplified LPV/r maintenance therapy in HIV patients on the 1 PI-based regimen.
abstract: OBJECTIVE
  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<200 copies/mL (P = 0.61). 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00159224.
authors: Fundacion Huesped, Buenos Aires, Argentina.
authors: Pedro
authors: P
authors: Cahn
authors: Julio
authors: J
authors: Montaner
authors: Patrice
authors: P
authors: Junod
authors: Patricia
authors: P
authors: Patterson
authors: Alejandro
authors: A
authors: Krolewiecki
authors: Jaime
authors: J
authors: Andrade-Villanueva
authors: Isabel
authors: I
authors: Cassetti
authors: Juan
authors: J
authors: Sierra-Madero
authors: Arnaldo David
authors: AD
authors: Casiró
authors: Raul
authors: R
authors: Bortolozzi
authors: Sergio Horacio
authors: SH
authors: Lupo
authors: Nadia
authors: N
authors: Longo
authors: Emmanouil
authors: E
authors: Rampakakis
authors: Nabil
authors: N
authors: Ackad
authors: John S
authors: JS
authors: Sampalis
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors; D006801:Humans; D061466:Lopinavir / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D057285:Precision Medicine / Q000379:methods*; D018894:Reverse Transcriptase Inhibitors; D019438:Ritonavir / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D061466:Lopinavir; D019438:Ritonavir