A roll-over study with rilpivirine for human immunodeficiency virus type 1 (HIV-1) infected subjects who participated in rilpivirine pediatric studies.
- Conditions
- HIV-1 InfectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2024-512889-33-00
- Lead Sponsor
- Janssen Sciences Ireland Unlimited Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 43
1. Subjects (or their legally acceptable representative) must sign an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)., 2. Subjects must be HIV-1 infected and must have previously been treated with RPV 25 mg qd (or weight-adjusted dose) in a clinical development pediatric study and completed the protocol-defined treatment period., 3. Subjects must benefit from treatment with RPV, according to the efficacy and safety criteria as set out in the protocol of the pediatric study with RPV the subject was participating in prior to this rollover study, and must be expected to continue to benefit from this treatment in the opinion of the investigator., 4. Subjects must be able and willing to comply with the current protocol requirements., 5. Subjects’ general medical condition, in the opinion of the investigator, does not interfere with participation in this study.
1. Subjects using disallowed concomitant treatment., 2. Pregnant subjects., 3. Female subjects of childbearing potential and non-vasectomized heterosexually active male subjects not willing to continue practicing birth control methods during the study and for =1 month after the end of the study., 4. Subjects who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.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
- Secondary Outcome Measures
Name Time Method