title: Does HAART efficacy translate to effectiveness? Evidence for a trial effect.
abstract: BACKGROUND
  Patients who participate in clinical trials may experience better clinical outcomes than patients who initiate similar therapy within clinical care (trial effect), but no published studies have evaluated a trial effect in HIV clinical trials.
  
  
  METHODS
  To examine a trial effect we compared virologic suppression (VS) among patients who initiated HAART in a clinical trial versus in routine clinical care. VS was defined as a plasma HIV RNA ≤ 400 copies/ml at six months after HAART initiation and was assessed within strata of early (1996-99) or current (2000-06) HAART periods. Risk ratios (RR) were estimated using binomial models.
  
  
  RESULTS
  Of 738 persons initiating HAART, 30.6% were women, 61.7% were black, 30% initiated therapy in a clinical trial and 67% (n =  496) had an evaluable six month HIV RNA result. HAART regimens differed between the early and current periods (p < 0.001); unboosted PI regimens (55.6%) were more common in the early and NNRTI regimens (46.4%) were more common in the current period. Overall, 78% (95%CI 74, 82%) of patients achieved VS and trial participants were 16% more likely to achieve VS (unadjusted RR 1.16, 95%CI 1.06, 1.27). Comparing trial to non-trial participants, VS differed by study period. In the early period, trial participants initiating HAART were significantly more likely to achieve VS than non-trial participants (adjusted RR 1.33; 95%CI 1.15, 1.54), but not in the current period (adjusted RR 0.98; 95%CI 0.87, 1.11).
  
  
  CONCLUSIONS
  A clear clinical trial effect on suppression of HIV replication was observed in the early HAART period but not in the current period.
authors.affiliation: Division of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
authors.forename: Prema
authors.initials: P
authors.lastname: Menezes
authors.forename: William C
authors.initials: WC
authors.lastname: Miller
authors.forename: David A
authors.initials: DA
authors.lastname: Wohl
authors.forename: Adaora A
authors.initials: AA
authors.lastname: Adimora
authors.forename: Peter A
authors.initials: PA
authors.lastname: Leone
authors.forename: William C
authors.initials: WC
authors.lastname: Miller
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D002986:Clinical Trials as Topic; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy; D006801:Humans; D008297:Male; D012367:RNA, Viral / Q000097:blood; D012307:Risk Factors; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D044966:Anti-Retroviral Agents; D012367:RNA, Viral