Association of plasma human immunodeficiency virus type 1 RNA level with risk of clinical progression in patients with advanced infection

R. W. Coombs, S. L. Welles, C. Hooper, P. S. Reichelderfer, R. T. D'Aquila, A. J. Japour, V. A. Johnson, D. R. Kuritzkes, D. D. Richman, S. Kwok, J. Todd, J. B. Jackson, V. Degruttola, C. S. Crumpacker, J. Kahn

Research output: Contribution to journalArticlepeer-review

152 Scopus citations

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-1 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 of HIV-1 RNA as a predictor for clinical end points has implications for the use of HIV-1 RNA in clinical trials and practice.

Original languageEnglish (US)
Pages (from-to)704-712
Number of pages9
JournalJournal of Infectious Diseases
Volume174
Issue number4
DOIs
StatePublished - 1996

Bibliographical note

Funding Information:
Grant support: NIH (AI-27664, -27757, -05030, -29293, -35172, -29193, -27659, -01101, -32794, -32775, -32770, -27670, -36214, -29164, -30457, -25879, -29173, -27763, -35172); Research Center for AIDS and HIV Infection of the VA Medical Center, San Diego (D.D.R.); General Clinical Research Center, University of Colorado, Denver (RR-0005!) (D.R.K.); Core Research Facilities of the University of Alabama at Birmingham Center for AIDS Research, and the VA Medical Center, Birmingham (V.A.].); UCSF AIDS Clinical Research Center, San Francisco (CC-93SFI30) (J.K.). This study was supported in part by Bristol-Myers Squibb, Roche Molecular Systems, and Chiron.

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