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Clinical Trial Summary

The purpose of this study is to determine the dosage for oral and IM Cabotegravir LA and IM Rilpiverine LA and evaluate the safety, acceptability, tolerability, and pharmacokinetics of oral and long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed HIV-infected children and adolescents.

Clinical Trial Description

This study will confirm the dose and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIV‐1 infected children and adolescents aged 12 to less than 18 years.

The study will include two cohorts of participants and two steps of study participation in each cohort. Cohort 1, Step 1 and Cohort 2, Step 3 are both a lead-in phase in which participants will receive oral formulations of the study products for at least 4 weeks, and up to 6 weeks (maximum). In Cohort 1, Step 2 and Cohort 2, Step 4, participants will receive injectable formulations of the study products. In each cohort, participants will enter the study in the oral lead-in phase (Step 1, or Step 3) and then transition to the injectable phase (Step 2, or Step 4) if eligibility criteria for the injectable phase are met. Cohort 1, Step 2, and Cohort 2, Step 4, participants, including those who prematurely permanently discontinue injectable study product, will continue on-study for an additional 48 weeks after their last study product injection, per the long-term safety and washout PK follow-up (LSFU) schedule.

The study will open to accrual in Cohort 1, in which participants, in addition to continuing their pre-study combination antiretroviral therapy (cART) regimen, will receive either oral CAB or oral RPV (Step 1) followed by either CAB LA or RPV LA (Step 2). Cohort 1 participants will be assigned either CAB (Cohort 1C) or RPV (Cohort 1R) based on their pre-study cART regimen. Participants will not stop their cART. An interim analysis of safety and PK data will be performed, and Cohort 2 will initially open to accrual based on these interim analyses; however, accrual at this stage will be limited to Cohort 1 participants who meet criteria to enter Cohort 2. After Cohort 1 is fully enrolled and a full cohort data analysis is performed, accrual into Cohort 2 will be opened to additional participants who were not previously enrolled in Cohort 1. Upon Cohort 2 Entry (i.e. Cohort 2, Step 3), all 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.

Participants in Cohort 1 will be followed for up to 64 weeks, and participants in Cohort 2 will be followed for up to 144 weeks. Enrolled parents/caregivers will complete a single qualitative phone interview. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03497676
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date March 2019
Completion date August 2023

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