title: Safety and efficacy of treatment switch to raltegravir plus tenofovir/emtricitabine or abacavir/lamivudine in patients with optimal virological control: 48-week results from a randomized pilot study (Raltegravir Switch for Toxicity or Adverse Events, RASTA Study).
abstract: BACKGROUND
  The Raltegravir Switch for Toxicity or Adverse Events (RASTA) Study is a 2-arm randomized pilot study exploring the safety and efficacy at 48 weeks of a treatment switch to raltegravir associated with tenofovir/emtricitabine or abacavir/lamivudine in patients with regimens with optimal virological control.
  
  
  METHODS
  Patients treated with stable protease inhibitor (PI)-, non-nucleoside reverse transcriptase inhibitor (NNRTI)-, or nucleoside reverse transcriptase inhibitor (NRTI)-based regimens, with HIV-RNA levels < 50 copies/ml for ≥ 3 months and a CD4 cell count > 200 cells/μl were eligible. Enrollment of 40 patients was planned: at baseline patients were randomized 1:1 to switch to raltegravir plus tenofovir/emtricitabine (arm A) or abacavir/lamivudine (arm B). Laboratory parameters, raltegravir plasma levels, self- reported adherence, quality of life parameters, neurocognitive performance, bone composition, and body fat distribution were monitored. Virological failure was defined as HIV-RNA > 50 copies/ml on 2 consecutive determinations.
  
  
  RESULTS
  After 48 weeks, 5/40 (12.5%) regimen discontinuations occurred: 2 were for low-level viremia virological failure (both in arm A, at weeks 24 and 48) and 3 were for adverse events (neurological disturbances and skin rash in arm B; proximal tubulopathy in arm A). Overall, a significant CD4 increase was observed at weeks 36 and 48, and a significant decrease in total cholesterol, non-high density lipoprotein cholesterol, and triglycerides was observed at each study visit. Physical health/satisfaction in therapy scores and neuropsychological performance improved. The lumbar column Z-score improved, with no modification in other bone composition and fat distribution parameters.
  
  
  CONCLUSIONS
  The investigated switch strategy was associated with rare virological failure. Improvements in lipid levels, quality of life measures, neuropsychological performance, and bone composition suggest good tolerability of raltegravir-based regimens.
authors.affiliation: From the Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart , Rome.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fabbiani
authors.forename: Annalisa
authors.initials: A
authors.lastname: Mondi
authors.forename: Manuela
authors.initials: M
authors.lastname: Colafigli
authors.forename: Gabriella
authors.initials: G
authors.lastname: D'Ettorre
authors.forename: Francesca
authors.initials: F
authors.lastname: Paoletti
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Avino
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Ciccarelli
authors.forename: Letizia
authors.initials: L
authors.lastname: Sidella
authors.forename: Rita
authors.initials: R
authors.lastname: Murri
authors.forename: Serena
authors.initials: S
authors.lastname: Fortuna
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Vullo
authors.forename: Roberto
authors.initials: R
authors.lastname: Cauda
authors.forename: Andrea
authors.initials: A
authors.lastname: De Luca
authors.forename: Simona
authors.initials: S
authors.lastname: Di Giambenedetto
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects* / Q000379:methods*; D018791:CD4 Lymphocyte Count; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011760:Pyrrolidinones / Q000009:adverse effects* / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D008055:Lipids; D011760:Pyrrolidinones; D012367:RNA, Viral; D000068898:Raltegravir Potassium