Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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
Description
This is a Phase I/II, multicenter, open-label, non-comparative study to evaluate the safety, tolerability, acceptability, and PK of oral CAB and oral RPV followed by long-acting injectable CAB (CAB LA) and long-acting injectable RPV (RPV LA) to propose the weight-band dosing in virologically suppressed children living with HIV-1 aged two to less than 12 years. The study will also assess the long-acting injectable regimen with and without an oral lead-in period in the same study population. Following completion of the study, if it is not possible for participants to access injections of CAB LA…
Eligibility
- Age range
- 2–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b * 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. Note: All sites must follow all applicable IRB/EC policies and procedures; for US sites, this includes single IRB (sIRB) policies and procedures. * Age two years old to less than 12 years old at entry * Body weight ≥10 kgs and \<40 kgs…
Interventions
- DrugOnce daily CAB tablet + RPV tablet
Tablet
- DrugLong acting CAB injectable + long acting RPV injectable
Injectable
- DrugLong acting CAB injectable + long acting RPV injectable
Injectable
Locations (12)
- Site 5030, Emory University School of Medicine NICHD CRSAtlanta, Georgia
- Site 6501, St. Jude Children's Research Hospital CRSMemphis, Tennessee
- Site 12701, Gaborone CRSGaborone
- Site 12702, Molepolole CRSGaborone
- Site 5073, SOM Federal University Minas Gerais Brazil NICHD CRSBelo Horizonte
- CRS 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research SiteRio de Janeiro