Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV

• Main Authors: Deborah Ford, Rebecca Turner, Anna Turkova, Martina Penazzato, Victor Musiime, Mutsa Bwakura-Dangarembizi, Avy Violari, Chishala Chabala, Thanyawee Puthanakit, Tavitiya Sudjaritruk, Tim R. Cressey, Marc Lallemant, Diana M. Gibb
• Format: Journal
• Published: 2018
• Subjects: Medicine
• Online Access: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85055149780&origin=inward; http://cmuir.cmu.ac.th/jspui/handle/6653943832/62807
• Institution: Chiang Mai University

For HIV-infected children, formulation development, pharmacokinetic (PK) data, and evaluation of early toxicity are critical for licensing new antiretroviral drugs; direct evidence of efficacy in children may not be needed if acceptable safety and PK parameters are demonstrated in children. However,...