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 Combination Therapy Studies

Janssen-Cilag International NV0 个研究点开始时间: 2024年5月24日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•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

•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 Participants who were withdrawn from the previous parent study that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.

发起方