title: Randomized clinical trial of lovastatin in HIV-infected, HAART naïve patients (NCT00721305).
abstract: BACKGROUND
  Evidence suggests that statins may modify the immune response against HIV. The aim was to evaluate the antiretroviral and immunomodulatory effects of lovastatin in HIV-infected patients, naïve for antiretroviral therapy.
  
  
  METHODS
  Randomized, double-blinded, placebo-controlled, phase-II clinical trial. Primary outcomes were plasma viral load and circulating CD4+ T cell count, after 6 and 12 months of treatment; secondary outcomes were CD8+ T cell count, expression of activation markers (CD38 and HLA-DR) on T cells, and clinical outcomes. With a power of 90% to detect both a decrease of 0.3 log10 in plasma HIV-1 RNA copies and an increase of 20% in the CD4+ T cell count, we estimated a required sample size of 110 HIV-infected patients (55 per group). The results were analyzed by a model of repeated measurements using Generalized Estimating Equations.
  
  
  RESULTS
  Patients were randomized to receive either lovastatin (n = 55) or placebo (n = 57). During the 12-month follow-up, there was no effect of lovastatin either on viral load (estimated average change = 0.157 copies/mL; CI 95% = -0.099 to 0.414), or on the CD4+ T cell count (estimated average change = -26.1 cells/μL; CI 95% = -89.8 to 37.6). Moreover, there were no significant differences in secondary outcomes.
  
  
  CONCLUSIONS
  Daily administration of lovastatin (40 mg) for one year in HIV-infected patients, naïve for antiretroviral therapy, had no significant effect on HIV replication, the CD4+ T cell count, or the activation level of T cells. (www.clinicaltrials.gov; ID NCT00721305).
authors.affiliation: Immunovirology Group, University of Antioquia, Calle 62, 52 - 59, Medellin, Colombia. cjmonto@gmail.com
authors.forename: Carlos J
authors.initials: CJ
authors.lastname: Montoya
authors.forename: Edwin A
authors.initials: EA
authors.lastname: Higuita
authors.forename: Santiago
authors.initials: S
authors.lastname: Estrada
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Gutierrez
authors.forename: Pedro
authors.initials: P
authors.lastname: Amariles
authors.forename: Newar A
authors.initials: NA
authors.lastname: Giraldo
authors.forename: Margarita M
authors.initials: MM
authors.lastname: Jimenez
authors.forename: Claudia P
authors.initials: CP
authors.lastname: Velasquez
authors.forename: Alba L
authors.initials: AL
authors.lastname: Leon
authors.forename: Maria T
authors.initials: MT
authors.lastname: Rugeles
authors.forename: Fabian A
authors.initials: FA
authors.lastname: Jaimes
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016516:CD4-CD8 Ratio; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005434:Flow Cytometry; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D008148:Lovastatin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D044966:Anti-Retroviral Agents; D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D002784:Cholesterol; D008148:Lovastatin