AIDS 2021 Apr 6. Epub 2021 Apr 6.
University of Colorado Anschutz Medical Campus, Aurora, CO Children's Hospital of Philadelphia, Philadelphia, PA Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, NY Frontier Science and Technology, Buffalo, NY Harvard School of Public Health, Boston, MA Shandukani Research Centre, Johannesburg, South Africa FHI 360, Durham, NC ColumbusUSA Technologies contract at NIAID, Maternal, Adolescent & Pediatric Research Branch, Rockville, MD Eunice Kennedy Shriver National Institute of Child Health & Human Development, Bethesda, MD IMPAACT Laboratory Center, University of California Los Angeles, Los Angeles, CA Preventive Medicine Department, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil Janssen, Research and Development, Beerse, Belgium.
Objective: To describe the pharmacokinetics (PK), safety, and efficacy of etravirine (ETR) in HIV-infected children 1 to < 6 yrs.
Design: Phase I/II, open label, multicenter, dose-finding study.
Methods: Antiretroviral (ARV)-experienced children in two age cohorts (I: 2-<6 yr; II: 1-<2 yr) received weight-based ETR, swallowed whole or dispersed in liquid, with optimized ARV therapy including a ritonavir-boosted protease inhibitor. Read More