IMPAACT 2017: Phase I/II Study of the Safety and Pharmacokinetics of Oral and Injectable Cabotegravir and Rilpivirine in Viriologically Suppressed HIV-Infected Adolescents

Study Status Study Restriction

In Development

United States

What is IMPAACT 2017?

IMPAACT 2017 is a Phase I/II, multi-centre, open-label, non-comparative study to confirm the dose and evaluate safety, tolerability, acceptability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in approximately 155 virologically suppressed, HIV-1 infected children and adolescents, aged 12 to less than 18 years.  Antiviral activity will be assessed as part of safety evaluations. Two sequential dosing cohorts will be enrolled:

  • Up to 55 virologically suppressed adolescents will be enrolled into Cohort I. Based on their current cART regimen, up to 30 participants will receive an adult daily oral dose of CAB and up to 25 participants will receive an adult daily oral dose of RPV for at least 4 weeks. After 4 weeks, eligible participants will then receive a single intramuscular injection of long-acting CAB (CAB LA) or long-acting RPV (RPV LA), respectively, every four weeks over an eight-week period. Participants will be followed for 48 weeks after completing the injection regimen to assess safety and PK washout, or until Cohort 2 enrollment begins. Participants in Cohort 1 will continue their cART regimen throughout Cohort 1 participation.
  • Up to 100 virologically suppressed adolescents will be enrolled into Cohort 2. Participants will stop their current cART regimen and initiate the adult daily dose of both oral CAB and oral RPV for at least 4 weeks. Participants will then receive intramuscular injections of both CAB LA and RPV LA every 4 weeks for at least 48 weeks. The doses of oral CAB, CAB LA, and RPV LA provided in Cohort 2 will be determined based on experience in Cohort 1. Regardless of their duration of follow-up on study drug, all participants will be followed for an additional 48 weeks (on cART, off study product) as part of long-term safety follow-up after their last study drug injection.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Co-Chair: Carolyn Bolton

Study Co-Chair: Aditya Gaur

DAIDS Medical Officer: Adeola Adeyeye

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Katherine Calabrese

Clinical Trials Specialist: Anna LeViere

Data Manager: Bobbie Graham

Laboratory Data Manager (LDM): Oswald Dadson

Laboratory Data Manager (LDM): Kyle Whitson

Laboratory Specialist: William Murtaugh

Protocol Pharmacist: Irene Rwakazina

Statistician: Carmelita Alvero

Statistician: Yan Wang

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.