Study Objectives

Primary Objectives

Cohort 1 (continuing a background cART regimen)

  • To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents by evaluating: 
    • Safety and multiple dose PK of oral CAB through Week 4
    • Safety and multiple dose PK of CAB LA through Week 16.
  • To confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16.

Cohort 2 (discontinuing a background cART regimen)

  • To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents.

Secondary Objectives

Cohort 1

  • To monitor maintenance of viral suppression through Week 16 in HIV-infected, virologically suppressed adolescents.
  • To evaluate the tolerability and acceptability of CAB LA through Week 16 in HIV-infected, virologically suppressed adolescents.
  • To evaluate the tolerability and acceptability of RPV LA through Week 16 in HIV-infected, virologically suppressed adolescents.

Cohort 2

  • To assess safety of oral CAB + oral RPV followed by CAB LA + RPV LA through Week 48 in HIV-infected, virologically suppressed adolescents.
  • To evaluate repeat-dose pharmacokinetics of CAB LA + RPV LA through Week 24, and through Week 48 in HIV-infected, virologically suppressed adolescents.
  • To assess antiviral activity of CAB LA + RPV LA through Week 24, and through Week 48 in HIV-infected, virologically suppressed adolescents.

Study Design

This is a Phase I/II, multi‐center, open‐label, non‐comparative study to confirm the dose and evaluate the safety, tolerability, acceptability, and PK of oral Cabotegravir (CAB), long-acting injectable Cabotegravir (CAB LA), and long-acting injectable Rilpivirine (RPV LA) among up to 155 virologically suppressed HIV‐1 infected children and adolescents aged 12 to <18 years

The study includes two cohorts(cohort 1 and 2) of participants and two steps of study participation in each cohort. 

In Cohort 1, participants, in addition to continuing their pre-study cART regimen, will receive either oral CAB or oral RPV (Step 1) followed by either CAB LA or RPV LA (Step 2).  

Cohort 2 participants will discontinue their pre-study cART regimen and receive both study products — CAB and RPV — at the doses confirmed in Cohort 1. 

Study Population and Size

HIV‐1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs.

Botswana sites (Gaborone, 12701 and Molepolole, 12702) plan to enroll a total of 25 participants across the 2 cohorts. Enrolment will vary within cohorts, i.e., accrual will not necessarily be equal among the cohorts but the number of participants in each cohort will be dependent on the number of potential participants found eligible for each cohort while the cohort is still open for enrolment. Enrollment into the study is on competitive basis and study sites may enroll based on their ability to identify potential participants and as much as their resources allow.

Study Duration: 7 years

Study Status: Ongoing

Sponsor: National Institute of Allergy and Infectious Diseases