title: Progression to AIDS or death as endpoints in HIV clinical trials.
abstract: OBJECTIVE
  To assess progression to AIDS or death from month 4 after a protease inhibitor-containing regimen is initiated in a cohort of 1,281 patients.
  
  
  METHODS
  We used Kaplan-Meier estimates of probability of clinical progression.
  
  
  RESULTS
  At month 4, most patients had an HIV-1 RNA plasma value below 500 copies/mL (78%) and a CD4 cell count above 300 cells/mm(3) (62%). Starting from month 4, clinical progression at 1 and 2 years of follow-up was low (<3% at 1 year) in patients with HIV RNA <500 copies/mL or 500-10,000 copies/mL and in patients with CD4 between 50 and 300 cells/mm(3) or >300 cells/mm(3). A higher risk of clinical progression (> or =10% at 1 year) was evidenced only in patients with poor response to antiretroviral therapy, that is, with CD4 <50 cells/mm(3) or CD4 between 50-300 cells/mm(3) together with an HIV RNA >10,000 copies/mL.
  
  
  CONCLUSIONS
  In patients currently on antiretroviral therapy, clinical trials with clinical progression as endpoint are almost not feasible, except in patients with a poor immunovirological response to first- or second-line HAART.
authors.affiliation: Infectious Diseases Department, University Hospital, Hôtel Dieu, Nantes, France. francois.raffi@wanadoo.fr
authors.forename: F
authors.initials: F
authors.lastname: Raffi
authors.forename: G
authors.initials: G
authors.lastname: Chêne
authors.forename: R
authors.initials: R
authors.lastname: Lassalle
authors.forename: T
authors.initials: T
authors.lastname: May
authors.forename: E
authors.initials: E
authors.lastname: Billaud
authors.forename: H
authors.initials: H
authors.lastname: Fleury
authors.forename: P
authors.initials: P
authors.lastname: Dellamonica
authors.forename: C
authors.initials: C
authors.lastname: Leport
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002986:Clinical Trials as Topic / Q000379:methods*; D018450:Disease Progression; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D012367:RNA, Viral / Q000097:blood; D016019:Survival Analysis; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D012367:RNA, Viral