The purpose of this guidance is to provide general recommendations on the development of antiretroviral (ARV) drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric (birth to younger than 18 years of age) patients. This guidance is intended to help sponsors understand when it is appropriate to initiate pediatric formulation development and to begin pediatric studies.
This guidance clarifies FDA’s current thinking on critical aspects of the development of pediatric HIV drug products intended for global use. The guidance for industry Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (November 2015) addresses more broadly the development of ARV drug products for the treatment of HIV infection.
This guidance does not address the full scope of considerations in the development program and clinical trial designs for ARV drug products to support an indication for the treatment of HIV-1 infection in adult or pediatric patients.