Principal Investigator : Ponego Lloyd Ponatshego  MD, MSc

Study Objectives:

Primary Objective

The primary objective of the 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 roll-over, experience and are expected to continue to experience clinical benefit from this treatment.

Secondary Objective

The secondary objective is to 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 considered to be related to the study intervention.

Study Design: This is a Phase 4, open-label, non-randomized, multicenter, multi-country, rollover study in participants living with HIV-1 infection who were treated in the parent studies with CAB LA + RPV LA given intramuscularly on a Q4W or Q8W dosing schedule. Final dosing information for children <12 years of age with a body weight <35 kg will be included via a protocol amendment once the data from the IMPAACT 2036 (CRAYON) study become available.

This rollover study will be conducted primarily to enable continued access to CAB LA + RPV LA and also to collect the long-term safety and tolerability data as specified in the Schedule of Activities of the study protocol in participants who completed the parent studies and who, at the time of rollover, experience and are expected to experience clinical benefit from the regimen, and have no other access to locally available CAB LA + RPV LA.

Access to study intervention in this rollover study will continue for up to 48 months (ie, 4 years), after which other treatment options (improved or equivalent, including potential oral ARVs) will be evaluated based on their availability and participant needs.

Study Population:

Participants living with HIV-1 infection who were treated with CAB LA + RPV LA in any of the following parent studies: TMC278LAHTX3002 (CARES), TMC278LAHTX3005 (IMPALA), IMPAACT 2017 (MOCHA), IMPAACT 2036 (CRAYON), IMPAACT 2040 (CREATE).

Sample Size:

Based on the number of participants in the parent studies, a maximum of 710 participants are expected to potentially rollover into the current study from study centers in Botswana, Kenya, South Africa, Uganda, and Thailand.

No formal sample size determination is performed for this study. Any participant receiving CAB LA + RPV LA and who has completed the parent studies and who has given consent/assent to participate and who is eligible and willing, may participate in this study.

As the parent studies are currently ongoing (MOCHA) or did not yet start (CRAYON), an exact sample size for participants in Botswana is not yet available.

Study Duration: 3.5 years

Sponsor: Janssen-Cilag International NV, a company organized and existing under the laws of Belgium, with its registered office at Turnhoutseweg 30, 2340 Beerse, Belgium