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.
Sequential
Once daily CAB tablet + RPV tablet
DrugTablet
Long acting CAB injectable + long acting RPV injectable
DrugInjectable
Long acting CAB injectable + long acting RPV injectable
DrugInjectable
AUC (Cohort 1, tablets)
Area under the curve from start of dose to 8 hours post dose
CL/F (Cohort 1, tablets)
apparent clearance from start of dose to 8 hours post dose
Cmax (Cohort 1, tablets)
Peak concentration from start of dose to 8 hours post dose
Tmax (Cohort 1, tablets)
Time of maximal concentration from start of dose to 8 hours post dose
Accumulation ratios Wk 24:Wk 8 and Wk 48: Wk 8 (Cohort 2a), Wk 20:Wk4 and Wk 44: Wk 4 (Cohort 2b
Ct prior to IM doses through Week. 24 and Week. 48 (Cohort 2a)
Ct prior to IM doses through Wk. 20 and Wk. 44 (Cohort 2b)
Proportion of children who experience a drug-related safety failure event through Weeks 48 and 72 of CAB + RPV (oral and injectable) (Cohort 1)
CAB and RPV concentrations 8 to 48 weeks following final IM dose
Proportion of children who experience a drug-related safety failure event through 48 weeks following permanent discontinuation of CAB LA + RPV LA
Proportion of children who experience a grade 3 or higher adverse event through 48 weeks following permanent discontinuation of CAB LA + RPV LA
Proportion of children who experience an SAE through 48 weeks following permanent discontinuation of CAB LA + RPV LA
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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