title: Analysis of relation between virologic responses and immunologic responses, patient's factors in AIDS clinical trials using a semiparametric mixed-effects model.
abstract: In this article we propose to use a semiparametric mixed-effects model based on an exploratory analysis of clinical trial data for a study of the relation between virologic responses and immunologic markers such as CD4+ and CD8 counts, and host-specific factors in AIDS clinical trials. The regression spline technique, used for inference for parameters in the model, reduces the unknown nonparametric components to parametric functions. It is simple and straightforward to implement the procedures using readily available software, and parameter inference can be developed from standard parametric models. We apply the model and the proposed method to an AIDS clinical study. Our findings indicate that viral load level is positively related to baseline viral load level, negatively related to CD4+ cell counts, but unrelated to CD8 cell counts and patient's age neither.
authors.affiliation: Department of Biostatistics and Computational Biology, University of Rochester Medical Center, 601 Elmwood Avenue, Box 630, Rochester, NY 14642, USA. hliang@bst.rochester.edu
authors.forename: Hua
authors.initials: H
authors.lastname: Liang
authors.forename: Guohua
authors.initials: G
authors.lastname: Zou
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D000998:Antiviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D006678:HIV / Q000276:immunology; D006801:Humans; D008954:Models, Biological; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D019562:Viral Load
chemical_list: D000998:Antiviral Agents