E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 Infection Infección por VIH-1 |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020192 |
E.1.2 | Term | HIV-1 |
|
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 |
El objetivo principal es seguir proporcionando ETR a los pacientes anteriormente tratados con dicho fármaco en un ensayo clínico pediátrico con el patrocinio o colaboración de Tibotec que sigan presentando una mejoría gracias a su uso, en aquellos países en los que ETR no se comercializa para uso pediátrico, su coste no se reembolse o no pueda obtenerse por otros medios (como programas de acceso o gubernamentales), o a cuando el paciente no sea apto para participar en los ensayos/programas con ETR en curso. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Los pacientes con una infección por el VIH-1 confirmada. 2. Los pacientes varones o mujeres de 6 años o más. Los pacientes menores de 6 años sólo podrán participar cuando se encuentren disponibles las recomendaciones posológicas referentes a ETR para este grupo de edad y el promotor las haya notificado a los investigadores, los comités éticos oportunos y las autoridades sanitarias. 3. Los pacientes que hayan completado de manera satisfactoria un ensayo clínico pediátrico con ETR con el patrocinio o la colaboración de Tibotec y sigan presentando una mejoría gracias a su uso. 4. Los pacientes (en su caso, dependiendo de la edad) y su padre, madre o representante legal han firmado voluntariamente el documento de consentimiento/asentimiento informado (DCI). A los niños se les explicará el ensayo y se les solicitará el asentimiento (en su caso, dependiendo de la edad). 5. Las mujeres en edad fértil con una prueba de embarazo negativa en orina.
1. Subjects with documented HIV-1 infection. 2. Male or female subjects, aged 6 years and older. Subjects younger than 6 years of age are only allowed to participate after ETR dose recommendations for that age group are available, and the sponsor has notified the investigators, applicable Ethics Committees, and Health Authorities. 3. Subject has successfully completed a clinical pediatric trial with ETR sponsored by or in collaboration with Tibotec, and continues to receive benefit from the use of ETR. 4. Subject (where appropriate, depending on age) and their parent(s) or legal representative(s) have signed the Informed Consent Form (ICF)/Assent voluntarily. Children will be informed about the program and asked to give assent (where appropriate, depending on age). 5. Negative urine pregnancy test for females of childbearing potential |
|
E.4 | Principal exclusion criteria |
1. Los pacientes con cualquier circunstancia (como alcoholismo y toxicomanía, entre otras) que, a criterio del investigador, pudiera comprometer la seguridad del paciente o el cumplimiento del tratamiento con ETR. 2. Los pacientes que presenten cualquier enfermedad activa con importancia clínica (p. ej., pancreatitis, disfunción cardíaca), antecedentes médicos, pruebas analíticas o exploración física que, en opinión del investigador, puedan comprometer la seguridad del paciente durante el tratamiento con ETR. 3. Los pacientes con alergia o hipersensibilidad con importancia clínica demostrada anteriormente a ETR o a cualquiera de sus excipientes. 4. Las mujeres embarazadas o en período de lactancia. 5. Los varones heterosexuales activos no sometidos a vasectomía que no empleen métodos anticonceptivos seguros y eficaces (véase la sección 5.2.4), o no se muestren dispuestos a seguir utilizando estos métodos durante el ensayo y, como mínimo, hasta 30 días tras su finalización (o tras la última dosis de la medicación en investigación). 6. Las chicas sexualmente activas y en edad fértil que no empleen métodos anticonceptivos seguros y eficaces (véase la sección 5.2.4), o no se muestren dispuestas a seguir utilizando estos métodos durante el ensayo y, como mínimo, hasta 30 días tras su finalización (o tras la última dosis de la medicación en investigación).
1. Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the subjects safety or adherence to treatment with ETR. 2. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the investigators opinion, would compromise the subjects safety during treatment with ETR. 3. Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR. 4. Pregnant or breastfeeding female subject. 5. Non-vasectomized heterosexually active boys not using safe and effective birth control methods (see Section 5.2.4), or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication). 6. Girls, who are sexually active and able to become pregnant, not using safe and effective birth control methods (see Section 5.2.4of the protocol), or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Hasta la disponsabilidad comercial para el uso pediatria, o acceso a través un otro origen (ej. Programa de acceso o programa de gobierno)
commercial availability for pediatric use, or access through another source (e.g. access program or government program) |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Entrega autorizacion continuado / Provide continued access |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 | Information not present in EudraCT |
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 |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |