title: Utility of routine viral load, CD4 cell count, and clinical monitoring among adults with HIV receiving antiretroviral therapy in Uganda: randomised trial.
abstract: OBJECTIVE
  To evaluate the use of routine laboratory monitoring in terms of clinical outcomes among patients receiving antiretroviral therapy (ART) in Uganda.
  
  
  METHODS
  Randomised clinical trial
  
  
  METHODS
  A home based ART programme in rural Uganda.
  
  
  METHODS
  All participants were people with HIV who were members of the AIDS Support Organisation. Participants had CD4 cell counts <250 cells × 10(6)/L or World Health Organization stage 3 or 4 disease.
  
  
  METHODS
  Participants were randomised to one of three different monitoring arms: a viral load arm (clinical monitoring, quarterly CD4 counts, and viral load measurements), CD4 arm (clinical monitoring and CD4 counts), or clinical arm (clinical monitoring alone).
  
  
  METHODS
  Serious morbidity (newly diagnosed AIDS defining illness) and mortality.
  
  
  RESULTS
  1094 participants started ART; median CD4 count at baseline was 129 cells × 10(6)/L. Median follow-up was three years. In total, 126 participants died (12%), 148 (14%) experienced new AIDS defining illnesses, and 61(6%) experienced virological failure, defined as two consecutive viral loads >500 copies/mL occurring more than three months after the start of ART. After adjustment for age, sex, baseline CD4 count, viral load, and body mass index, the rate of new AIDS defining events or death was higher in the clinical arm than the viral load arm (adjusted hazard ratio 1.83, P = 0.002) or the CD4 arm (1.49, P = 0.032). There was no significant difference between the CD4 arm and the viral load arm (1.23, P = 0.31).
  
  
  CONCLUSIONS
  In patients receiving ART for HIV infection in Uganda, routine laboratory monitoring is associated with improved health and survival compared with clinical monitoring alone. Trial registration Clinical Trials NCT00119093.
authors.affiliation: Global AIDS Program, Centers for Disease Control and Prevention-Uganda, Entebbe, Uganda.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mermin
authors.forename: John P
authors.initials: JP
authors.lastname: Ekwaru
authors.forename: Willy
authors.initials: W
authors.lastname: Were
authors.forename: Richard
authors.initials: R
authors.lastname: Degerman
authors.forename: Rebecca
authors.initials: R
authors.lastname: Bunnell
authors.forename: Frank
authors.initials: F
authors.lastname: Kaharuza
authors.forename: Robert
authors.initials: R
authors.lastname: Downing
authors.forename: Alex
authors.initials: A
authors.lastname: Coutinho
authors.forename: Peter
authors.initials: P
authors.lastname: Solberg
authors.forename: Lorraine N
authors.initials: LN
authors.lastname: Alexander
authors.forename: Jordan
authors.initials: J
authors.lastname: Tappero
authors.forename: James
authors.initials: J
authors.lastname: Campbell
authors.forename: David M
authors.initials: DM
authors.lastname: Moore
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D016903:Drug Monitoring; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D016012:Poisson Distribution; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D014454:Uganda / Q000453:epidemiology; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents
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