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.
Bibliographical noteFunding 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.