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, 2 cohort study to evaluate pharmacokinetics, safety and tolerability of oral and injectable Cabotegravir (CAB) and Rilpivirine (RPV) in approximately 140 HIV-1 infected adolescents 12 – 18 years of age. Two sequential dosing cohorts will be enrolled:

  • Up to 40 virologically suppressed adolescents will be enrolled into Cohort I. Based on their current cART regimen, approximately 25 participants will receive an adult daily dose of CAB and approximately 15 participants will receive an adult daily dose of RPV for at least 4 weeks. After 4 weeks, participants will receive three once per month intramuscular injections of CAB or RPV, respectively. Participants will be followed for 52 weeks after completing the injection regimen, or until Cohort 2 enrollment begins, for safety and virologic outcomes.
  • Up to 100 virologically suppressed adolescents will be enrolled into Cohort 2. Participants will stop their current antiretroviral therapy and initiate the adult daily dose of both oral CAB and RPV for at least 4 weeks. Participants will then receive intramuscular injections of both CAB and RPV every 4 weeks for 48 weeks. After the completion of the last injection dose, participants will resume their cART regimen and followed for 52 weeks for safety outcomes.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Chair: Carolyn Bolton

Study Vice-Chair: Aditya Gaur

DAIDS Medical Officer: Devasena Gnanashanmugam

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: JL Ariansen

Clinical Trials Specialist: Katherine Calabrese

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.