TMC278LAHTX4002: A 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.
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202404524950258
- Lead Sponsor
- Janssen Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 710
Participants (or their legally acceptable representative) must sign an informed consent form indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study
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), and completed the protocol-defined treatment period
- Has benefited clinically from treatment with CAB LA + RPV LA in the opinion of the investigator
- Must be able and willing to comply with the rollover protocol requirements
- Participant’s general medical condition, in the opinion of the investigator, does not interfere with participation in this study
Participants using disallowed concomitant treatment
Participants who were withdrawn from the previous parent study with CAB LA + RPV LA that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method