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A key objective in two phase 2b AMP clinical trials of VRC01 is to evaluatewhether drug concentration over time, as estimated by non-linear mixed effectspharmacokinetics (PK) models, is associated with HIV infection rate. Weconducted a simulation study of marker sampling designs, and evaluated theeffect of study adherence and sub-cohort sample size on PK model estimates inmultiple-dose studies. With m=120, even under low adherence (about half ofstudy visits missing per participant), reasonably unbiased and consistentestimates of most fixed and random effect terms were obtained. Coarsened markersampling schedules were also studied.

Pharmacokinetics Simulations for Studying Correlates of Prevention  Efficacy of Passive HIV-1 Antibody Prophylaxis in the Antibody Mediated  Prevention (AMP) Study