title: A pilot study of switch to lopinavir/ritonavir (LPV/r) monotherapy from nonnucleoside reverse transcriptase inhibitor-based therapy.
abstract: OBJECTIVE
  This study evaluated the safety and efficacy of switching HIV-infected patients with stable viral suppression on nonnucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) therapy to lopinavir/ritonavir (LPV/r) monotherapy.
  
  
  METHODS
  Eligible patients discontinued NNRTI and started LPV/r. Two weeks later NRTIs were stopped and LPV/r monotherapy was continued. Patients were seen every 4 weeks throughout the 48-week study.
  
  
  RESULTS
  Twelve of 18 (66%) participants met the primary endpoint with HIV RNA <75 copies/mL at week 48. Thirteen (72%) participants completed 48 weeks of LPV/r monotherapy, and 12 of 13 (92%) participants on treatment at week 48 had HIV RNA <75 copies/mL. Ten (55%) of 18 patients maintained HIV RNA <75 copies/mL at all time points. Two patients were withdrawn with virologic failure but demonstrated no evidence of virologic resistance. Three (17%) patients withdrew due to diarrhea, 2 with hyperglycemia at baseline developed diabetes mellitus, 7 (54%) required addition of or increase in lipid-lowering agents, but none had grade 3 or 4 hyperlipidemia.
  
  
  CONCLUSIONS
  Results from this pilot study suggest that LPV/r monotherapy may be an option for management of HIV infection. Larger, randomized trials are warranted to evaluate the safety, efficacy, and patient population who might benefit from LPV/r monotherapy.
authors.affiliation: AIDS Research and Treatment Center of Treasure Coast, Ft. Pierce, Florida, USA. pieroneg@bellsouth.net
authors.forename: Gerald
authors.initials: G
authors.lastname: Pierone
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Mieras
authors.forename: Dorothy
authors.initials: D
authors.lastname: Bulgin-Coleman
authors.forename: Chandra
authors.initials: C
authors.lastname: Kantor
authors.forename: James
authors.initials: J
authors.lastname: Shearer
authors.forename: Lunie
authors.initials: L
authors.lastname: Fontaine
authors.forename: Michael
authors.initials: M
authors.lastname: Fath
authors.forename: Michael
authors.initials: M
authors.lastname: Norton
mesh_terms: D023241:Antiretroviral Therapy, Highly Active; D003967:Diarrhea / Q000209:etiology; D004334:Drug Administration Schedule; D023381:Endpoint Determination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D006943:Hyperglycemia / Q000209:etiology; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D011744:Pyrimidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D018894:Reverse Transcriptase Inhibitors; D061466:Lopinavir; D019438:Ritonavir