Cabotegravir + Rilpivirine Long-Acting Injection Rollover Study

Phase 1

Conditions: Human Immunodeficiency Virus 1
MedDRA version: 20.1Level: LLTClassification code 10020443Term: Human immunodeficiency virus syndromeSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2023-001064-26-Outside-EU/EEA

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Participants (or their legally acceptable representative) must sign an ICF indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study.
2. Participants living with HIV-1 infection who were treated in
any of the parent studies and completed the protocol-defined treatment period.
3. Has benefited clinically from treatment in the opinion of the investigator.
4. Must be able and willing to comply with the rollover protocol requirements.
5. Participant’s general medical condition, in the opinion of the investigator, does not interfere with participation in this study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 214
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participants using disallowed concomitant treatment.
2. Participants who were withdrawn from the previous parent study that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to provide continued access to participants who were enrolled and treated in the parent studies, and<br>who, at the time of rollover experience clinical benefit from this treatment.;Secondary Objective: The secondary objective is to assess the long-term safety and tolerability of CAB + RPV by evaluating the incidence of serious adverse events, pregnancies, and adverse events.;Primary end point(s): No primary endpoint is defined for this study.;Timepoint(s) of evaluation of this end point: Not applicable.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety laboratory tests may be performed, as determined necessary by the investigator or required by local regulations at any time during the participant’s participation in the study. Assessments will be performed per local standard of care and not collected in the eCRF; no additional study-specific blood sampling will be required.;Timepoint(s) of evaluation of this end point: Throughout the study.