Association of Plasma Human Immunodeficiency Virus Type 1 RNA Level withRisk of Clinical Progression in Patients with Advanced Infection

Authors:
  • SWS. L. Welles
    S. L. Welles
  • CHC. Hooper
    C. Hooper
  • PRP. A. Reichelderfer
    P. A. Reichelderfer
  • RDR. T. D'AQuila
    R. T. D'AQuila
  • AJA. J. Japour
    A. J. Japour
  • DKD. R. Kuritzkes
    D. R. Kuritzkes
  • DRD. D. Richman
    D. D. Richman
  • SKS. Kwok
    S. Kwok
  • JTJ. Todd
    J. Todd
  • VDV. DeGruttola
    V. DeGruttola
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Abstract
Human immunodeficiency virus (HIV)-1 RNA level in plasma was evaluated as a surrogate marker for disease progression in a clinical trial of advanced HIV-1 infection. Baseline HIV-l RNA level was an independent predictor of disease progression (relative hazard [RH] for each doubling of HIV-1 RNA level, 1.26; 95% confidence interval [CI], 1.03-1.54; P = .02), after adjusting for the week 4 change in HIV-1 RNA level, baseline CD4 cell count, syncytium-inducing phenotype, clinical status at study entry, and therapy randomization. A 50% reduction in HIV-1 RNA level was associated with a 27% decrease in the adjusted risk of disease progression during the study (RH, 0.73; 95% CI, 0.52-1.02; P = .07). The partial validation ofHIV-1 RNA as a predictor for clinical end points has implications for the use of HIV-1 RNA in clinical trials and practice.