title: Viral load as a primary outcome in human immunodeficiency virus trials: a review of statistical analysis methods.
abstract: In Human Immunodeficiency Virus infection, several statistical methods are available to analyze viral load (HIV-1 RNA) used as a surrogate outcome in trials of antiretroviral treatments. We compared the most frequently used methods and applied them to one of these trials, where HIV-1 RNA was measured using two lower limits of detection. Methods were reviewed for different properties dealing with validity, interpretation, and handling. Compared to change of HIV-1 RNA at the end of follow-up or HIV-1 RNA area-under-the-curve during follow-up minus baseline, the most attractive methods appeared to be HIV-1 RNA undetectability, HIV-1 RNA reduction at the end of follow-up with censoring adjustment, and mixed linear model on HIV-1 RNA.
authors.affiliation: INSERM U330, 146 rue Léo Saignat, 33076 Bordeaux Cedex, France. valerie.journot@bordeaux.inserm.fr
authors.forename: V
authors.initials: V
authors.lastname: Journot
authors.forename: G
authors.initials: G
authors.lastname: Chêne
authors.forename: P
authors.initials: P
authors.lastname: Joly
authors.forename: M
authors.initials: M
authors.lastname: Savès
authors.forename: H
authors.initials: H
authors.lastname: Jacqmin-Gadda
authors.forename: J M
authors.initials: JM
authors.lastname: Molina
authors.forename: R
authors.initials: R
authors.lastname: Salamon
mesh_terms: D019540:Area Under Curve; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D016014:Linear Models; D012367:RNA, Viral / Q000097:blood; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors