title: CD4 deficit and tuberculosis risk persist with delayed antiretroviral therapy: 5-year data from CIPRA HT-001.
abstract: METHODS
  Port-au-Prince, Haiti.
  
  
  OBJECTIVE
  To determine long-term effects of early vs. delayed initiation of antiretroviral therapy (ART) on immune recovery and tuberculosis (TB) risk in human immunodeficiency virus (HIV) infected individuals.
  
  
  METHODS
  Open-label randomized controlled trial of immediate ART in HIV-infected adults with CD4 counts between 200 and 350 cells/mm(3) vs. deferring ART until the CD4 count was <200 cells/mm(3). The primary comparisons were CD4 counts over time and risk for incident TB, with 5 years of follow-up.
  
  
  RESULTS
  A total of 816 participants were enrolled, with 408 in each treatment arm. The early treatment group started ART within 2 weeks, while the deferred treatment group started ART a median of 1.3 years after enrollment. After 5 years, the mean CD4 count in the early treatment group was significantly higher than in the deferred treatment group (496 cells/mm(3), 95% confidence interval [CI] 477-515 vs. 373 cells/mm(3), 95%CI 357-389; P < 0.0001). TB risk was higher in the deferred treatment group (unadjusted HR 2.41, 95%CI 1.56-3.74; P < 0.0001) and strongly correlated with lower CD4 counts in time-dependent multivariate analysis.
  
  
  CONCLUSIONS
  Delays in ART initiation for HIV-infected adults with CD4 counts of 200-350 cells/mm(3) can result in long-term immune dysfunction and persistent increased risk for TB.
authors.affiliation: Center for Global Health, Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
authors.forename: S E
authors.initials: SE
authors.lastname: Collins
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port au Prince, Haiti.
authors.forename: M A
authors.initials: MA
authors.lastname: Jean Juste
authors.affiliation: Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: S P
authors.initials: SP
authors.lastname: Koenig
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port au Prince, Haiti.
authors.forename: R
authors.initials: R
authors.lastname: Secours
authors.affiliation: Center for Global Health, Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
authors.forename: O
authors.initials: O
authors.lastname: Ocheretina
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port au Prince, Haiti.
authors.forename: D
authors.initials: D
authors.lastname: Bernard
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port au Prince, Haiti.
authors.forename: C
authors.initials: C
authors.lastname: Riviere
authors.affiliation: Analysis Group, Inc. Boston, Massachusetts, USA.
authors.forename: M
authors.initials: M
authors.lastname: Calnan
authors.affiliation: Department of Public Health, Weill Cornell Medical College, New York, New York, USA.
authors.forename: A
authors.initials: A
authors.lastname: Dunning
authors.affiliation: Department of Public Health, Weill Cornell Medical College, New York, New York, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Hurtado Rúa
authors.affiliation: Center for Global Health, Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
authors.forename: W D
authors.initials: WD
authors.lastname: Johnson
authors.affiliation: Center for Global Health, Department of Medicine, Weill Cornell Medical College, New York, New York, USA; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port au Prince, Haiti.
authors.forename: J W
authors.initials: JW
authors.lastname: Pape
authors.affiliation: Center for Global Health, Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
authors.forename: D W
authors.initials: DW
authors.lastname: Fitzgerald
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port au Prince, Haiti.
authors.forename: P
authors.initials: P
authors.lastname: Severe
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D006205:Haiti; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D013997:Time Factors; D061665:Time-to-Treatment / Q000706:statistics & numerical data*; D014376:Tuberculosis / Q000453:epidemiology* / Q000276:immunology
chemical_list: D044966:Anti-Retroviral Agents