title: The setpoint study (ACTG A5217): effect of immediate versus deferred antiretroviral therapy on virologic set point in recently HIV-1-infected individuals.
abstract: BACKGROUND
  The benefits of antiretroviral therapy during early human immunodeficiency virus type 1 (HIV-1) infection remain unproved.
  
  
  METHODS
  A5217 study team randomized patients within 6 months of HIV-1 seroconversion to receive either 36 weeks of antiretrovirals (immediate treatment [IT]) or no treatment (deferred treatment [DT]). Patients were to start or restart antiretroviral therapy if they met predefined criteria. The primary end point was a composite of requiring treatment or retreatment and the log(10) HIV-1 RNA level at week 72 (both groups) and 36 (DT group).
  
  
  RESULTS
  At the June 2009 Data Safety Monitoring Board (DSMB) review, 130 of 150 targeted participants had enrolled. Efficacy analysis included 79 individuals randomized ≥72 weeks previously. For the primary end point, the IT group at week 72 had a better outcome than the DT group at week 72 (P = .005) and the DT group at week 36 (P = .002). The differences were primarily due to the higher rate of progression to needing treatment in the DT group (50%) versus the IT (10%) group. The DSMB recommended stopping the study because further follow-up was unlikely to change these findings.
  
  
  CONCLUSIONS
  Progression to meeting criteria for antiretroviral initiation in the DT group occurred more frequently than anticipated, limiting the ability to evaluate virologic set point. Antiretrovirals during early HIV-1 infection modestly delayed the need for subsequent treatment.
  
  
  BACKGROUND
  NCT00090779.
authors.affiliation: Department of Medicine, Medical College of Wisconsin, Milwaukee, USA. chogan@mcw.edu
authors.forename: Christine M
authors.initials: CM
authors.lastname: Hogan
authors.forename: Victor
authors.initials: V
authors.lastname: Degruttola
authors.forename: Xin
authors.initials: X
authors.lastname: Sun
authors.forename: Susan A
authors.initials: SA
authors.lastname: Fiscus
authors.forename: Carlos
authors.initials: C
authors.lastname: Del Rio
authors.forename: C Bradley
authors.initials: CB
authors.lastname: Hare
authors.forename: Martin
authors.initials: M
authors.lastname: Markowitz
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Connick
authors.forename: Bernard
authors.initials: B
authors.lastname: Macatangay
authors.forename: Karen T
authors.initials: KT
authors.lastname: Tashima
authors.forename: Beatrice
authors.initials: B
authors.lastname: Kallungal
authors.forename: Rob
authors.initials: R
authors.lastname: Camp
authors.forename: Tia
authors.initials: T
authors.lastname: Morton
authors.forename: Eric S
authors.initials: ES
authors.lastname: Daar
authors.forename: Susan
authors.initials: S
authors.lastname: Little
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D061466:Lopinavir / Q000627:therapeutic use*; D008297:Male; D063065:Organophosphonates / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000627:therapeutic use*; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D063065:Organophosphonates; D012367:RNA, Viral; C558899:lopinavir-ritonavir drug combination; D003841:Deoxycytidine; D061466:Lopinavir; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; D019438:Ritonavir