Cabotegravir And Rilpivirine: Efficacy and Safety Study

Project Summary

What is CARES?

Cabotegravir And Rilpivirine: Efficacy and Safety Study (CARES) is research project that aims to make taking medication easier for people living with HIV in sub-Saharan Africa. Many people on combination anti-retroviral therapy (cART) must take many pills each day to maintain their health and well-being. CARES offers an alternative: injectable medication taken 6 times per year. Because this regimen offers the benefit of reduced dosing from daily pills to injections every 2 months, the study is expected to demonstrate whether or not this could have a positive impact on the patient’s quality-of-life, improve adherence to treatment, improve engagement in care and reduce the stigma associated with the daily use of oral pills.

How is the trial organized?

It is a randomised clinical trial being done at eight sites in three African countries: Uganda, Kenya, and South Africa. Participants who are eligible for the trial are randomly allocated to either stay on the oral tablet form of their HIV treatment or to switch to two monthly injections of the HIV medicines Cabotegravir and Rilpivirine (CAB + RPV LA).

Both groups are followed up for a total of 24 months, with periodic assessments to determine how effective the medicines are working and if there are any safety concerns. Specifically, we monitor and shall compare the following between the two groups.

  1. Viral load response and the CD4 counts. These will show us how well controlled the virus is and how the immunity of participants is responding to the treatment.
  2. Side effects and tolerability to the medications.
  3. Development of resistance by the virus against anti- HIV medicines

In addition to these, we shall interview participants and health workers to determine their perspectives on the use of these injectable medicines

Who is participating in CARES?

The trial is following up on 512 participants, who were recruited at the 8 trial sites which are showcased in this website.

What does CARES hope to achieve?

  • Obtain data on virological efficacy from appropriate populations with background risk of resistance, viral subtypes.

  • Obtain data on efficacy, safety and tolerability of CAB LA + RPV LA with treatment administered using a monitoring strategy feasible in the public health approach in SSA.

  • Obtain data on efficacy of LA treatment administered with resources for treatment and follow-up typical of the public health approach (and with representative patient values and perceptions)

  • Obtain data that can inform treatment utility (Quality of Life) and costs to inform cost-effectiveness modelling

Trial Schema