E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020161 |
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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 of this trial is to continue the provision of DRV for pediatric Subjects who have completed treatment with DRV in the clinical trials TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 sponsored by Tibotec Pharmaceuticals, and who continue to benefit from using it, in countries where DRV is not commercially available for the pediatric subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, governmental program) |
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E.2.2 | Secondary objectives of the trial |
In addition, information on the safety of DRV/rtv in combination with other ARVs will be assessed |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subjects, aged 3 years and above. 2. Subject has completed the TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 trial, and in the opinion of the investigator continues to receive benefit from using DRV. 3. DRV is not commercially available for the pediatric subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, government program) in the region the subject is living in. 4. Subject (where appropriate, depending on age) and the parent(s) or legal representative(s) have signed the Informed Consent Form voluntarily. Children will be informed about the program and asked to give assent (where appropriate, depending on age). |
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E.4 | Principal exclusion criteria |
Any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise subjects’ safety or adherence to treatment with DRV. 2. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the opinion of the investigator, would compromise subjects’ safety during treatment with DRV. 3. Previously demonstrated clinically significant allergy or hypersensitivity to DRV or to ritonavir, or any of the excipients of DRV or ritonavir. 4. Pregnant or breastfeeding female subjects. 5. Female subject of childbearing potential without use of effective birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period. Note: Estrogen hormonal based contraception may not be reliable when taking DRV/rtv. Therefore, to be eligible for this trial female subjects of childbearing potential should either: a. Use a double-barrier method to prevent pregnancy (i.e., use a male condom with either diaphragm or cervical cap)*; or b. Use non-estrogen hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); or c. Use an intra-uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); or d. Be non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile). * A male and female condom should not be used together due to the risk of breakage or damage caused by latex friction. 6. Heterosexually active male subject not using effective birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this trial is to continue the provision of DRV for pediatric subjects who have completed treatment with DRV in the clinical trials TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 sponsored by Tibotec Pharmaceuticals, and who continue to benefit from using it, in countries where DRV is not commercially available for the pediatric subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, governmental program) |
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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 | No |
E.6.4 | Safety | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
continuare a fornire il trattamento |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |