title: The impact of reducing stavudine dose versus switching to tenofovir on plasma lipids, body composition and mitochondrial function in HIV-infected patients.
abstract: BACKGROUND
  Stavudine (d4T)-containing regimens are associated with a potential for lipoatrophy and dyslipidaemia. We assessed the safety and efficacy of reducing the dose of stavudine compared with switching to tenofovir or maintaining the standard dose of d4T.
  
  
  METHODS
  Clinically stable HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg twice daily with a plasma HIV RNA < 200 copies/ml for at least 6 months were randomized to maintain stavudine 40 mg twice daily (d4T40 arm), to reduce to 30 mg twice daily (d4T30 arm), or to switch from d4T to tenofovir (TDF arm).
  
  
  RESULTS
  Fifty-eight (93% male) patients were included: 22 in the d4T40 arm, 19 in the d4T30 arm and 17 in TDF arm. At baseline, median time on d4T was 6 years (interquartile range [IQR] 2.6-7.1), median age 43 years (IQR 36-51) and median CD4+ T-cell count was 587/mm3 (IQR 329-892). At week 24, median limb fat changes (g) were as follows: d4T40 = -182 (95% CI: -469- -5); d4T30 = 527 (95% CI: -343-694); and TDF = 402 (95% CI: 130-835; d4T40 versus TDF, P = 0.0003). Significant differences between median values of laboratory parameters were detected: triglycerides (mg/dl): d4T40 = 19; d4T30 = -23 and TDF = -79 (d4T40 versus TDF, P = 0.03); and total cholesterol (mg/dl): d4t40 = 22, d4T30 = -4, and TDF = -28 (d4T40 versus TDF, P = 0.04). No significant difference was observed in mitochondrial function assessed in peripheral blood mononuclear cells.
  
  
  CONCLUSIONS
  Although both strategies were associated with a trend toward a decrease in plasma lipids and an increase in body fat, the only significant changes were observed among those who switched to tenofovir.
authors.affiliation: Infectious Diseases Unit, Hospital Clinic Barcelona, Barcelona, Spain. anamilinkovic@hotmail.com
authors.forename: Ana
authors.initials: A
authors.lastname: Milinkovic
authors.forename: Esteban
authors.initials: E
authors.lastname: Martinez
authors.forename: Sonia
authors.initials: S
authors.lastname: López
authors.forename: Elisa
authors.initials: E
authors.lastname: de Lazzari
authors.forename: Oscar
authors.initials: O
authors.lastname: Miró
authors.forename: Sergi
authors.initials: S
authors.lastname: Vidal
authors.forename: José L
authors.initials: JL
authors.lastname: Blanco
authors.forename: Gloria
authors.initials: G
authors.lastname: Garrabou
authors.forename: Montserrat
authors.initials: M
authors.lastname: Laguno
authors.forename: Joan A
authors.initials: JA
authors.lastname: Arnaiz
authors.forename: Agathe
authors.initials: A
authors.lastname: Leon
authors.forename: Maria
authors.initials: M
authors.lastname: Larrousse
authors.forename: Montserrat
authors.initials: M
authors.lastname: Lonca
authors.forename: Josep
authors.initials: J
authors.lastname: Mallolas
authors.forename: José M
authors.initials: JM
authors.lastname: Gatell
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001823:Body Composition; D002784:Cholesterol / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006678:HIV; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000378:metabolism; D008060:Lipodystrophy / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D008928:Mitochondria / Q000378:metabolism; D063065:Organophosphonates / Q000627:therapeutic use*; D010101:Oxygen Consumption; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use*; D000068698:Tenofovir; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D014280:Triglycerides; D002784:Cholesterol; D000068698:Tenofovir; D018119:Stavudine; D000225:Adenine