Etravirine in treatment-experienced HIV-1-infected children 1 year to less than 6 years of age.

ABSTRACT:

Objective

To describe the pharmacokinetics, safety, and efficacy of etravirine (ETR) in HIV-infected children 1 to less than 6 years of age.

Design

Phase I/II, open-label, multicenter, dose-finding study.

Methods

Antiretroviral therapy (ART)-experienced children in two age cohorts (I: 2 to <6 years; II: 1 to less than 2 years) received weight-based ETR, swallowed whole or dispersed in liquid, with optimized ART including a ritonavir-boosted protease inhibitor. Intensive pharmacokinetics occurred 7-18 days after starting ETR. Participants with ETR AUC12h less than 2350 ng h/ml had a dose increase and repeat pharmacokinetics.

Results

Twenty-six children enrolled and 21 (15 in cohort I and 6 in cohort II) had evaluable intensive pharmacokinetics sampling at the fi

SUBMITTER: MacBrayne CE 

PROVIDER: S-EPMC8270511 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature