Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Etravirine in treatment-experienced HIV-1-infected children 1 year to less than 6 years of age
AIDS, Volume 35, No. 9, Year 2021
Notification
URL copied to clipboard!
Description
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 AUC12hless 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 final weight-based dose. On the final dose, the geometric mean ETR AUC12hwas 3823 ng h/ml for cohort I and 3328 ng h/ml for cohort II. Seven children (33.3%) on the final dose, all taking ETR dispersed, had an AUC12 hless than 2350 ng h/ml and underwent a dose increase. ETR AUC12 hwas 3.8-fold higher when ETR was swallowed whole vs. dispersed, P less than 0.0001. On the final dose, 75 and 33.3% in cohorts I and II, respectively, had HIV-1 RNA 400 copies/ml or less or at least 2 log reductions from baseline at week 48. Three children (11.5%) experienced a grade at least 3 adverse event related to ETR but only 1 discontinued.Conclusion:ETR was well tolerated. Predefined pharmacokinetics targets were met but overall exposures were low vs. historical data in adults, particularly in young children taking dispersed tablets. A high rate of viral efficacy was observed among those aged 2 to more than 6 years but not in those less than 2 years. © 2021 Lippincott Williams and Wilkins. All rights reserved.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC8270511/bin/aids-35-1413-s001.docx
Authors & Co-Authors
Rutstein, Richard M.
United States, Philadelphia
The Children's Hospital of Philadelphia
Wiznia, Andrew A.
United States, New York
Jacobi Medical Center
Graham, Bobbie L.
Unknown Affiliation
Alvero, Carmelita G.
United States, Boston
Harvard T.h. Chan School of Public Health
Fairlie, Lee
Unknown Affiliation
Lypen, Kathryn D.
United States, Durham
Fhi 360
George, Kathleen H.
United States, Durham
Fhi 360
Townley, Ellen
Unknown Affiliation
Moye, John
United States, Bethesda
National Institute of Child Health and Human Development Nichd
Costello, Diane G.
United States, Los Angeles
University of California, Los Angeles
Reding, Christina A.
Unknown Affiliation
Crauwels, Herta M.
Belgium, Beerse
Janssen Research & Development
Tambuyzer, Lotke
Belgium, Beerse
Janssen Research & Development
Vanveggel, Simon
Belgium, Beerse
Janssen Research & Development
Opsomer, Magda
Belgium, Beerse
Janssen Research & Development
Kiser, Jennifer J.
United States, Aurora
University of Colorado Anschutz Medical Campus
Statistics
Citations: 5
Authors: 16
Affiliations: 9
Identifiers
Doi:
10.1097/QAD.0000000000002902
ISSN:
02699370
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study