title: Lower CD4 cell count and higher virus load, but not antiretroviral drug resistance, are associated with AIDS-defining events and mortality: an ACTG Longitudinal Linked Randomized Trials (ALLRT) analysis.
abstract: BACKGROUND
  We hypothesized that drug resistance mutations would impact clinical outcomes associated with HIV-1 infection.
  
  
  METHODS
  A matched case-control study of participants in AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT). Cases experienced an AIDS-defining event (ADE) or mortality, and controls did not. One hundred thirty-four cases were identified and matched to a total of 266 controls by age, sex, treatment regimen, and length of follow-up. Both cases and controls had HIV RNA levels of ≥ 500 copies/mL within 24 weeks of an event. Population-based genotyping at or near the time of the event was used to evaluate the impact of resistance mutations on incidence of ADE and/or death using conditional logistic regression models.
  
  
  RESULTS
  One hundred four cases and 183 controls were analyzed. Median time to event was 99 weeks; 6 cases were deaths. At baseline, cases had lower CD4 (median 117 vs 235 cells/mm3; P < .0001) and higher HIV RNA levels (median 205,000 vs 57,000 copies/mL; P = .003). No significant differences in resistance were seen between cases and controls.
  
  
  CONCLUSIONS
  In this rigorously designed case-control study, lower CD4 cell counts and higher virus loads, not antiretroviral drug resistance, were strongly associated with ADE and mortality.
authors.affiliation: University of Nebraska Medical Center, Omaha, NE, USA. sswindells@unmc.edu
authors.forename: Susan
authors.initials: S
authors.lastname: Swindells
authors.forename: Hongyu
authors.initials: H
authors.lastname: Jiang
authors.forename: A Lisa
authors.initials: AL
authors.lastname: Mukherjee
authors.forename: Mark
authors.initials: M
authors.lastname: Winters
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Bosch
authors.forename: David
authors.initials: D
authors.lastname: Katzenstein
authors.lastname: Aids Clinical Trials Group
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000276:immunology / Q000401:mortality* / Q000821:virology; D000328:Adult; D018791:CD4 Lymphocyte Count; D016022:Case-Control Studies; D024882:Drug Resistance, Viral; D005260:Female; D006801:Humans; D016015:Logistic Models; D008137:Longitudinal Studies; D008297:Male; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D019562:Viral Load