The combination of CAB LA and RPV LA has been shown in clinical trials in virologically suppressed adults living with HIV to be safe, well-tolerated and efficacious as a complete injectable antiretroviral regimen.
The primary objective of this study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of rollover, experience clinical benefit from this treatment, but do not have access to locally available CAB LA + RPV LA to continue treatment. The parent studies include; IMPAACT 2017 [MOCHA], IMPAACT 2036 [CRAYON], TMC278LAHTX3002 [CARES], and TMC278LAHTX3005 [IMPALA]. The rollover study will be reviewed periodically to evaluate other access options.
The participants receive CAB LA + RPV LA given intramuscularly on a once every 4 weeks (Q4W) or every 8 weeks (Q8W) dosing schedule. The study will also assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CAB LA + RPV LA, and AEs (excluding Grade 1 and Grade 2 injection site reactions) considered to be related to the study intervention.
Expected impact: This study enables continued access to CAB LA + RPV LA and allows for the evaluation of the long-term safety and tolerability of CAB LA + RPV LA.
