CARES is a randomized, open-label, active-controlled, multicenter, interventional study in virologically suppressed (<50 c/mL) HIV-1 infected adult participants with a total follow up period of 24 months.
Main Inclusion and exclusion Criteria
Eligible participants stable on first-line cART containing 2 nucleoside reverse transcriptase inhibitor (NRTIs; tenofovir [TDF] plus either lamivudine [3TC] or emtricitabine [FTC]) plus an INI (dolutegravir [DTG]) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz [EFV] or nevirapine [NVP]) were randomised to either of two arms
1039 participants were screened to enrol the targeted 512 participants across 8 sites from 3 countries (3 sites in Uganda, 3 sites in Kenya and 2 sites in South Africa).
Screen failures due to history of exposure to Hepatitis B virus (HBV) with no evidence of active disease were further tested for immunity against HBV
Because the CAB LA+RPV LA regimen offers the benefit of reduced dosing from daily pills to IM 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. Furthermore, the study also aims to show whether or not this has the potential to improve adherence to treatment, improve engagement in care and reduce the stigma associated with the daily use of oral pills.
The CARES study also aims to investigate whether CAB LA+RPV LA administered every 2 months is non-inferior to SOC in resource limited settings, where the majority of the population affected by HIV-1 consists of black African women, and where access to regular clinical and laboratory monitoring is more challenging.
In the course of screening, we eliminated almost half of all participants due to exposure to Hepatitis B despite having a negative HBsAg. We aim to investigate the best approach to screening for this TDF and 3TC/FTC sparing regimen in a public health setting
Furthermore, in most Sub-Saharan Africa (SSA) countries, resistance to NNRTIs has reached levels greater than 10% (WHO HIV Drug Resistance Report, 2017), which has necessitated a switch to INI-based regimens for durable virologic control.
This study also aims to bridge other data gaps specific to SSA including choice for OLI and the lived experiences on CAB LA+RPV LA
Finally , the economic evaluation will support the policy recommendations from the CARES trial
Overall, the trial is expected to inform future policy on the use of CAB LA+RPV LA especially in public health settings in SSA