Principal Investigator: Gaerolwe R. Masheto, MD

Study Objectives:

Primary Objectives: Cohort 1

• To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable) through Week 24
• To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oral and injectable) through Week 24

Secondary Objectives: Cohort 1

• To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
• To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA through Weeks 48 and 72
• To assess the maintenance of viral suppression of CAB + RPV (oral and injectable) through Weeks 24, 48, and 72
• To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA through Weeks 24, 48, and 72
• To describe HIV-1 genotypes and phenotypes for children who experience virologic failure during study treatment
• To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24, 48, and 72

Secondary Objectives: Cohort 2

• To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable) and 44 weeks of CAB LA + RPV LA (injectable only)
• To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
• To describe the maintenance of viral suppression and immunologic activity of 48 weeks of CAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
• To describe HIV-1 genotypes and phenotypes for children who experience virologic failure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CAB LA + RPV LA (injectable only)

Study Design:

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.

Study Population and Size:

Children living with HIV-1, two years to less than 12 years of age and weighing ≥10 kg and <40 kg, who are virologically suppressed on stable antiretroviral therapy and their parents/caregivers.

Globally the study will be conducted among up to 90 children weighing ≥10 kgs and <40 kgs, who are virologically suppressed on stable ART.  In Botswana we plan to enroll up to 20 participants in total

Study duration: 3 and a half years

Study Results: Study is on-going and no results yet.

Sponsor: