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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 infection |
E.1.2 | System Organ Class | 100000004862 |
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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 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 other ARVs. 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 |
Each potential subject must satisfy all of the following criteria to be enrolled in the study. 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. |
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E.4 | Principal exclusion criteria |
Any potential subject who meets any of the following criteria will be excluded from participating in the study. 1. Subjects using disallowed concomitant treatment. 2. Pregnant subjects. 3. Female subjects of childbearing potential and 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
No primary endpoint is defined for this study |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Major Secondary Endpoints: The proportion of subjects experiencing adverse events (AEs) considered to be at least possibly related to RPV, AEs leading to discontinuation, serious AEs (SAEs), pregnancies, and grade 3/4 rash regardless of causality throughout the study. Results of routine safety laboratory tests will only be collected if related to these types of AEs. 2. Other Secondary Endpoint: The proportion of subjects maintaining viral suppression based on available viral load data throughout the study. In case of virologic failure, emergence of resistance will also be evaluated based on available genotype/phenotype data. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 and 2. Throughout the study |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
1. To provide continued access to RPV 2. Tolerability |
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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 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
South Africa |
Thailand |
Uganda |
Spain |
Italy |
Portugal |
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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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LVLS
RPV will continue to be provided through this roll-over study until all subjects have switched to one of the following options, as appropriate for the subject’s age: (1) locally available RPV (if commercially available AND reimbursed, OR accessible through another source), (2) other locally available RPV-based regimens, or (3) local standard of care. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 29 |
E.8.9.2 | In all countries concerned by the trial years | 10 |