The dramatic increase in the number and type of immune biomarkers that can be measured, particularly those assessing immune activation, has led to numerous investigations in HIV-infected individuals to explore pathogenesis and to assess therapeutic interventions that aim to attenuate immune activation. An overview is provided on study designs and related statistical and operational issues relevant to these investigations.
Cohort studies and nested case–control studies within these cohorts have identified multiple biomarkers that are associated with an increased risk of disease. Early-stage clinical trials of therapies to address these risks in HIV-infected individuals with viral suppression on antiretroviral therapy are a substantial focus of current HIV research.
Appropriate study design is essential in biomarker research.
aCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts
bHuman Immunology Section, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA
Correspondence to Ronald J. Bosch, Center for Biostatistics in AIDS Research, 651 Huntington Avenue, FXB-603, Harvard School of Public Health, Boston, MA 02115, USA. Tel: +1 617 432 3024; fax: +1 617 432 2843; e-mail: firstname.lastname@example.org