The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age
Parent or legal guardian is willing and able to provide written permission for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation.
Age two years old to less than 12 years old at entry
Body weight ≥10 kg and <40 kg at entry
At entry, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee.
Within 6 months prior to entry, any HIV-1 RNA value >400 copies/mL OR two consecutive "viral blips," defined as an HIV-1 RNA value ≥50 copies/mL but ≤400 copies/mL.
As determined by the IoR or designee, and based on available medical records, known or suspected resistance to NNRTIs.
As determined by the IoR or designee, and based on available medical records, known or suspected resistance to INSTIs.
Ongoing congestive heart failure, symptomatic arrhythmia, or any current clinically significant cardiac disease, as determined by the IoR or designee, and based on available medical records.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator