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.

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 Long-acting.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202404524950258

Enrollment

710

Registered

2024-04-12

Start date

2024-05-31

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Cabotegravir Long acting Injection and Rilpivirine Long acting Injection CAB LA and RPV LA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Participants using disallowed concomitant treatment Participants who were withdrawn from the previous parent study with CAB LA + RPV LA that they were participating in prior to this rollover study, based on any of the mandatory withdrawal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

Design outcomes

Primary

Measure	Time frame
Number of Participants Who Continued to Receive Cabotegravir and Rilpivirine Long-Acting Injections	—

Secondary

Measure	Time frame
Number of Participants with Adverse Events (AEs) Related to Study Intervention;Number of Participants with AEs Leading to Discontinuation;Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Pregnancies	—

Countries

Botswana, Kenya, South Africa, Uganda

Contacts

Public ContactAwhonukeh ;Caroline Idahosa;Macharia

Study Responsible Scientist;Regional Trial Manager

aidahosa@its.jnj.com;cmachari@its.jnj.com+2349062886695;+2349062886695

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026