CARLA (TMC278LAHTX4002)

Rationale

Long-acting injectable antiretroviral therapy represents an important development in HIV treatment, offering an alternative to daily oral medication. The CARLA Study enables eligible participants who have completed previous clinical studies of long-acting HIV treatment to continue receiving CAB LA and RPV LA where the treatment is not locally available through standard care. The study will also contribute to longer-term evidence on the safety and tolerability of the treatment in participants who continue the regimen following completion of their parent studies.

Primary Objective

The primary objective is to provide continued access to CAB LA and RPV LA for eligible participants who previously received the treatment in parent studies and who are expected to continue to benefit clinically from the regimen.

Secondary Objective

The study will assess the long-term safety and tolerability of CAB LA and RPV LA by monitoring:

• Serious adverse events
• Adverse events that may lead to treatment discontinuation
• Adverse events considered related to the study intervention
• Pregnancy outcomes, where applicable

Investigators

Dr Faeezah Patel – Principal Investigator
Prof Lee Fairlie – Sub-Investigator
Dr Elizea Horne – Sub-Investigator
Dr Mrinmayee Dhar – Sub-Investigator
Dr Jeanne Coetzee – Sub-Investigator

Latest updated: July 2026

For further information: please email rhicomms@wrhi.ac.za