E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Síndrome de inmunodeficiencia adquirida (SIDA) |
|
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
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 |
Evaluar los resultados clínicos a largo plazo, incluyendo los riesgos de desarrollo de enfermedades malignas, episodios indicativos de SIDA y muerte en sujetos participantes en ensayos clínicos con VCV a los que se haya dejado de administrar el fármaco objeto de estudio. |
|
E.2.2 | Secondary objectives of the trial |
Evaluar la evolución del tropismo viral en plasma en sujetos tras la interrupción de la administración de VCV en comparación con sujetos sin historia de exposición a VCV. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
El sujeto debe cumplir con todos los criterios abajo enumerados para su inclusión en el registro: Los sujetos deben haber participado en un estudio Fase 2 o 3 con VCV, y deben de haber dejado de recibir el fármaco del estudio, con independencia de la exposición a VCV (p.ej., pueden incluirse también sujetos que hayan recibibo placebo que no hayan tenido exposición al VCV durante el estudio). |
|
E.4 | Principal exclusion criteria |
El sujeto quedará excluido si se le puede aplicar alguno de los criterios abajo enumerados: El sujeto no desea participar en el registro o proporcionar el consentimiento informado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Los criterios principales de valoración del registro son los siguientes: Incidencia de enfermedades malignas; Incidencia de episodios indicativos de SIDA (enumerados en la Sección 5.2); Tasa de mortalidad. |
|
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 |
Assess long-term clinical outcomes, development of malignancies, AID-defining events & death |
|
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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
|
Último paciente de la última visita (lo cual ocurrirá 5 años depués de que discontinúe el último paciente del anterior estudio de vicriviroc fase 2-3) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |