The CARES trial is a phase 3b, randomized, open label clinical trial evaluating the efficacy, safety, and tolerability of switching to cabotegravir long-acting (CAB LA) plus rilpivirine long-acting (RPV LA) in virologically suppressed HIV-1 infected adults on oral antiretrovirals in Sub-Saharan Africa.
It is a collaborative research between The Joint Clinical Research Centre (JCRC), Uganda and Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), involving eight sites in Uganda, Kenya and South Africa..
This research builds on work previously done on long-acting antiretroviral therapy, mostly in Europe and the Americas. The CARES trial focuses on the African continent which has the largest burden of disease, and where the health care systems, care and treatment strategies, culture and populations significantly differ.
This trial comes at a time when the WHO has recommended the use of long-acting antiretrovirals for pre-exposure prophylaxis for HIV. CARES will play an important part in informing future policy for anti-retroviral therapy particularly in resource limited settings.
A target of 512 participants, will be enrolled in this study and randomized 1:1 to either continue on their ART or switch to the intervention for a treatment period of 24 months. Eligible participants must meet the following criteria: