A roll-over study with rilpivirine for human immunodeficiency virus type 1 (HIV-1) infected participants who participated in the rilpivirine pediatric studies
- Conditions
- HIV-1 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002471-28-Outside-EU/EEA
- Lead Sponsor
- Janssen Sciences Ireland UC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 100
- Participants (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)
- Participants must be human immunodeficiency virus type 1 (HIV-1) infected and must have previously been treated with rilpivirine (RPV) 25 mg qd (or weight adjusted dose) in a clinical development pediatric study and completed the protocol defined treatment period
- Participants 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 participant 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
- Participants must be able and willing to comply with the current protocol requirements
- Participants 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: 89
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Participants using disallowed concomitant treatment
- Pregnant participants
- Female participants of childbearing potential and non-vasectomized heterosexually active male participants not willing to continue practicing birth control methods during the study and for greater than or equal to (=)1 month after the end of the study (or after last intake of RPV)
- Participants who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria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 Timepoint(s) of evaluation of this end point: Up to 32 Days from the last dose administered;Main Objective: The primary objective of this study 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.;Secondary Objective: The major secondary objective is to evaluate the long-term safety and tolerability of RPV in combination with a background regimen containing 2 N(t)RTIs. Another secondary objective is to evaluate available efficacy data, including HIV-1 resistance data in case of virologic failure.;Primary end point(s): Number of participants with adverse events (AEs) related to rilpivirine (RPV)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable