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R. W. Coombs, S. L. Welles, C. Hooper, P. A. Reichelderfer, R. T. D'Aquila, A. J. Japour, D. R. Kuritzkes, D. D. Richman, S. Kwok, J. Todd, J. B. Jackson, V. DeGruttola, C. S. Crumpacker, J. Kahn, Association of Plasma Human Immunodeficiency Virus Type 1 RNA Level with Risk of Clinical Progression in Patients with Advanced Infection, The Journal of Infectious Diseases, Volume 174, Issue 4, October 1996, Pages 704–712, https://doi.org/10.1093/infdis/174.4.704
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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.