A roll-over study with rilpivirine for human immunodeficiency virus type 1 (HIV-1) infected subjects who participated in rilpivirine pediatric studies.

Phase 2

Active, not recruiting

• Conditions: HIV-1 Infection

• Registration Number: 2024-512889-33-00
• Lead Sponsor: Janssen Sciences Ireland Unlimited Company

Brief Summary

The primary objective is to provide continued access to RPV for subjects who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from RPV treatment.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

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.

Exclusion Criteria

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 Subjects who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.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
No primary endpoint is defined for this study.		No primary endpoint is defined for this study.

Trial Locations

Locations (2)

Bambino Gesu Childrens Hospital; 🇮🇹 Rome, Italy

Azienda Ospedaliera Universitaria Federico II Di Napoli; 🇮🇹 Naples, Italy

Bambino Gesu Childrens Hospital

🇮🇹Rome, Italy

Stefania Bernardi

Site contact

390668592190

stefania.bernardi@opbg.net