E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
E.1.2 | Term | HIV infection |
|
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 |
Valorar la seguridad a largo plazo en los sujetos incluidos en los estudios con UK 453,061 para el tratamiento de la infección por VIH 1 |
|
E.2.2 | Secondary objectives of the trial |
No hay objetivos secundarios. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Prueba de un documento de consentimiento informado, firmado y fechado personalmente, que indique que se ha informado al sujeto (o a su representante legal) de todos los aspectos pertinentes del estudio. 2. Participación previa en un ensayo clínico con UK 453,061 en los 42 días anteriores. 3. Varones y mujeres de al menos 18 años. 4. Sujetos que quieran y puedan cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio. 5. Empleo de un anticonceptivo de barrera eficaz para las mujeres en edad fértil (MEF) y todos los varones. Además, las MEF deben utilizar otro método anticonceptivo aceptable durante toda la duración del estudio, Los anticonceptivos aceptables son, entre otros, el tratamiento hormonal oral, implantable o inyectable y los dispositivos intrauterinos. NOTA: se define como MEF a todas aquellas mujeres con menarquia y que no se han sometido a una esterilización quirúrgica satisfactoria o no son posmenopáusicas (ej. no han menstruado en al menos los dos últimos años). Deberán considerarse mujeres con capacidad de procrear incluso aquellas que estén utilizando anticonceptivos hormonales orales, implantables o inyectables o anticonceptivos mecánicos (dispositivos intrauterinos, métodos de barrera como el preservativo y el diafragma con espermicida) para evitar el embarazo, que practiquen la abstinencia sexual o cuya pareja sea estéril (p. ej., vasectomía). |
|
E.4 | Principal exclusion criteria |
1. El sujeto no está dispuesto a someterse a un seguimiento durante 12 meses o no es posible hacer dicho seguimiento. 2 El sujeto está recibiendo tratamiento de forma concomitante en otro ensayo clínico. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Seguridad evaluada mediante acontecimientos adversos. |
|
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 | 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 | No |
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) | 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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |