title: Pravastatin in HIV-infected patients treated with protease inhibitors: a placebo-controlled randomized study.
abstract: OBJECTIVE
  The objectives of the study were to assess the effects of pravastatin on plasma HIV RNA, lipid parameters, and protease inhibitor (PI) concentrations in patients treated with PI-containing regimens and with total cholesterol (TC) > or = 5.5 mmol/L.
  
  
  METHODS
  A clinical trial including patients randomized to receive pravastatin or matching placebo for 12 weeks was implemented.
  
  
  RESULTS
  Twelve patients were included in the pravastatin group and 9 in the placebo group. At week 12 (W12), no patient had experienced virological failure. Between week 0 (W0) and W12, the median differences for TC were -1.4 mmol/L in the pravastatin group and +0.2 mmol/L in the placebo group (p = .005); for LDL, they were -1.0 mmol/L and +0.3 (p = .007), respectively. A significant decrease of the PI concentration (12 hours after administration) ratio W12 - W0/W0 was noticed in the pravastatin group (-0.2 [interquartile range, -0.3 to -0.1] as compared with the placebo group (0.1 [IQR, 0.0 to 0.3]) (p = .03). When the study was restricted to patients treated with lopinavir/ritonavir, a decrease from 3.8 microg/mL at baseline to 2.9 mug/mL at W12 was noticed in the pravastatin arm (p = .04) but not in the control arm (p = 1.00). No clinical adverse event reached a severity of grade 3.
  
  
  CONCLUSIONS
  We observed in this study that the use of pravastatin in PI-treated patients was not associated with major change in the plasma HIV RNA on 12 weeks of follow-up. However, we found a trend of decrease of the trough PI concentration at W12, suggesting a possible drug-drug interaction of pravastatin on PI metabolism.
authors: Service de Médecine Interne et Maladies Infectieuses, Hôpital Saint-André, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France. fabrice.bonnet@chu-bordeaux.fr
authors: Fabrice
authors: F
authors: Bonnet
authors: Valerie
authors: V
authors: Aurillac-Lavignolle
authors: Dominique
authors: D
authors: Breilh
authors: Rodolphe
authors: R
authors: Thiébaut
authors: Evelyne
authors: E
authors: Peuchant
authors: Noëlle
authors: N
authors: Bernard
authors: Denis
authors: D
authors: Lacoste
authors: François
authors: F
authors: Dabis
authors: Jacques
authors: J
authors: Beylot
authors: Geneviève
authors: G
authors: Chêne
authors: Philippe
authors: P
authors: Morlat
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004347:Drug Interactions; D023381:Endpoint Determination; D005260:Female; D006678:HIV / Q000235:genetics / Q000302:isolation & purification*; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D017320:HIV Protease Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D053419:Lipoproteins, IDL / Q000097:blood; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000008:administration & dosage* / Q000009:adverse effects; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D017320:HIV Protease Inhibitors; D053419:Lipoproteins, IDL; D012367:RNA, Viral; D017035:Pravastatin