E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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 |
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E.4 | Principal exclusion criteria |
- 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of participants with adverse events (AEs) related to rilpivirine (RPV) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 32 Days from the last dose administered |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Kenya |
South Africa |
Thailand |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Subjects will receive RPV treatment until one of the following criteria is met (whichever comes first):
• The subject meets at least one of the withdrawal criteria, or
• RPV is licensed for adult/pediatric use (depending on the age of the subject) and/or is available/accessible to subjects outside of a clinical study setting. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 15 |
E.8.9.2 | In all countries concerned by the trial months | 5 |