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Wits RHI

IMPAACT 2040 (CREATE Study)

Vaccine Preventable Diseases

IMPAACT 2040, also known as the CREATE Study, is a Phase I/II clinical trial evaluating the pharmacokinetics and safety of long-acting injectable cabotegravir (CAB LA) and rilpivirine (RPV LA) in pregnant and postpartum women living with HIV-1. The study aims to support the development of long-acting antiretroviral therapy (ART) options that can improve health outcomes for women during and after pregnancy.

Long-acting ART regimens administered monthly or every two months offer a promising alternative to daily oral treatment by addressing key barriers such as pill burden, daily adherence, and concerns about disclosure. These regimens may significantly enhance both maternal and infant health in the context of HIV-1 care.

The study will be conducted at the Wits RHI Shandukani Clinical Research Site, which brings substantial expertise in long-acting injectable ART trials, having contributed to similar studies like MOCHA and CRAYON, which focused on adolescent and paediatric populations.

Primary Objective

To evaluate the pharmacokinetics and safety of long-acting injectable cabotegravir and rilpivirine in pregnant and postpartum women living with HIV-1.

Rationale

Pregnancy presents unique challenges for HIV treatment adherence. Long-acting injectable ART has the potential to:

  • Simplify treatment through less frequent dosing

  • Improve adherence and virologic suppression

  • Reduce the stigma and daily reminders associated with oral medication
    This study will contribute valuable data to determine whether these benefits can extend to women during the critical periods of pregnancy and postpartum care.

Study Population

Pregnant and postpartum women living with HIV-1

Study Timeline

  • Planned Start of Enrolment: Late Q1 2025

Investigators

  • Dr Mrinmayee Dhar, Principal Investigator

Latest Update

March 2025

For more information about IMPAACT 2040, please email rhicomms@wrhi.ac.za.