IMPAACT 2017 Study
IMPAACT 2017 is a Phase I/II Study of 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.
Rationale
The IMPAACT 2017 study aims to assess the efficacy of a two-drug, long-acting injectable regimen—CAB LA and RPV LA—in maintaining viral suppression among HIV-positive adolescents currently on antiretroviral therapy (ART). Starting with adolescents aged 12 to under 18, the findings from this age group may inform future research protocols involving younger children.
Primary Objectives
- Cohort 1 (continuing a background cART regimen)
- Confirm doses for oral CAB and CAB LA by evaluating safety and pharmacokinetics (PK) over 16 weeks.
- Confirm doses for injectable RPV LA by assessing its safety and PK through 16 weeks.
- Cohort 2 (discontinuing background cART regimen)
- Assess the safety of CAB LA + RPV LA over a 24-week period.
Secondary and Exploratory Objectives
This study also seeks to evaluate tolerability, acceptability, and long-term safety of CAB LA and RPV LA through 96 weeks in HIV-positive adolescents. Other objectives include exploring the adolescent and caregiver experience of injectable treatment.
This study supports ongoing efforts to advance pediatric HIV care by exploring innovative treatment options that prioritize safety, convenience, and efficacy for young people living with HIV.
Investigators
- Dr Faeezah Patel, Principal Investigator
- Prof Lee Fairlie, Sub Investigator
- Dr Elizea Horne, Sub Investigator
- Dr Mrinmayee Dhar, Sub Investigator
- Dr Muneerah Khan, Sub Investigator
- Dr Pemphero Chasela, Sub Investigator
- Dr Jeanne Coetzee, Sub Investigator
Latest Update
October 2024
For more about IMPAACT 2017 Study please email rhicomms@wrhi.ac.za
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