Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Status:
Completed
Trial end date:
2017-05-18
Target enrollment:
Participant gender:
Summary
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral
replication. Raltegravir is a drug that prevents integrase from working properly. This drug
has been tested for safety and efficacy in adults, but this is the first study to examine
raltegravir in children and adolescents. The purpose of this study was to determine the
appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of
age, by acquiring short and long term safety data, intensive and population pharmacokinetic
(PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)