title: Directly administered antiretroviral therapy for HIV-infected drug users does not have an impact on antiretroviral resistance: results from a randomized controlled trial.
abstract: BACKGROUND
  Directly administered antiretroviral therapy (DAART) is an effective intervention that improves clinical outcomes among HIV-infected drug users. Its effects on antiretroviral drug resistance, however, are unknown.
  
  
  METHODS
  We conducted a community-based, prospective, randomized controlled trial of DAART compared with self-administered therapy (SAT). We performed a modified intention-to-treat analysis among 115 subjects who provided serum samples for HIV genotypic resistance testing at baseline and at follow-up. The main outcomes measures included total genotypic sensitivity score, future drug options, number of new drug resistance mutations (DRMs), and number of new major International AIDS Society (IAS) mutations.
  
  
  RESULTS
  The adjusted probability of developing at least 1 new DRM did not differ between the 2 arms (SAT: 0.41 per person-year [PPY], DAART: 0.49 PPY; adjusted relative risk [RR] = 1.04; P = 0.90), nor did the number of new mutations (SAT: 0.76 PPY, DAART: 0.83 PPY; adjusted RR = 0.99; P = 0.99) or the probability of developing new major IAS new drug mutations (SAT: 0.30 PPY, DAART: 0.33 PPY; adjusted RR = 1.12; P = 0.78). On measures of GSS and FDO, the 2 arms also did not differ.
  
  
  CONCLUSIONS
  In this trial, DAART provided on-treatment virologic benefit for HIV-infected drug users without affecting the rate of development of antiretroviral medication resistance.
authors.affiliation: Yale University AIDS Program, Yale University School of Medicine, New Haven, CT 06510-2283, USA.
authors.forename: Duncan Smith-Rohrberg
authors.initials: DS
authors.lastname: Maru
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Kozal
authors.forename: R Douglas
authors.initials: RD
authors.lastname: Bruce
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Springer
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Altice
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D024882:Drug Resistance, Viral / Q000235:genetics; D004358:Drug Therapy / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012646:Self Administration; D019966:Substance-Related Disorders / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D044966:Anti-Retroviral Agents