| Protocol No: | ECCT/24/07/02 | Date of Protocol: | 12-01-2024 |
| Study Title: | A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Longacting Combination Therapy Studies |
| 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 rollover, 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. |
| Laymans Summary: | Cabotegravir (CAB) is a potent integrase strand transfer inhibitor (INSTI) with attributes allowing formulation and delivery as a long-acting (LA) parenteral product. Rilpivirine (RPV), also formulated as a LA product, is a diarylpyrimidine derivative and a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type HIV-1 and select NNRTI-resistant mutants. 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. This study enables continued CAB LA + RPV LA access to participants who were included in the clinical development studies for CAB LA + RPV LA (IMPAACT 2017 [MOCHA], IMPAACT 2036 [CRAYON], IMPAACT 2040 [CREATE], TMC278LAHTX3002 [CARES], TMC278LAHTX3005 [IMPALA], in the following sections referred to as the parent studies) and who continue to benefit clinically from the regimen but do not have access to locally available CAB LA + RPV LA to continue treatment. The rollover study will be reviewed periodically to evaluate other access options. |
| Abstract of Study: | This rollover study will be conducted primarily to enable continued access to CAB LA + RPV LA and also to collect long-term safety and tolerability data as specified in the Schedule of Activities in participants who completed the parent studies and who at the time of rollover, experience and are expected to continue to experience clinical benefit from the regimen, and have no other access to locally available CAB LA + RPV LA. At the time of rollover, the investigator should assess whether the participant still benefit clinically from CAB LA + RPV LA treatment according to the antiviral activity and safety criteria as set out in the protocol of the parent study that the participant was participating in prior to this rollover study. The investigator should also be confident that the participant is expected to continue to experience clinical benefit from CAB LA + RPV LA treatment. Participation in the rollover study is voluntary, and the decision to participate must be made jointly by the investigator and the participant or legally acceptable representative. Participants who do not opt to transition to the rollover study at the end of the CAREs study will be switched to SOC ART per local regulations and availability. |