Assessing pharmacokinetic marker correlates of outcome, with application to antibody prevention efficacy trials.

ABSTRACT: The Antibody Mediated Prevention efficacy trials are the first studies to evaluate whether passive administration of a broadly neutralizing monoclonal antibody can prevent human immunodeficiency virus (HIV) acquisition. The trials randomize 4600 HIV-negative volunteers to receive 10 infusions of the monoclonal antibody VRC01 or placebo. The primary objective compares the incidence of HIV infection between the study groups. The secondary objective assesses whether and how a marker defined as the serum concentration of VRC01 over time associates with the instantaneous rate of HIV infection, using a two-phase sampling design, a pharmacokinetic model for the time-concentration curve, and an estimator of HIV infection times. While a Cox model with a time-dependent covariate constitutes an impor

SUBMITTER: Gilbert PB 

PROVIDER: S-EPMC6736712 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature