E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
HIV POSITIVE / AIDS DIAGNOSED PATIENTS |
|
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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008922 |
E.1.2 | Term | Chronic infection with HIV |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 |
DETERMINAR LA CONCENTRACIÓN DE ETRAVIRINA EN SEMEN |
|
E.2.2 | Secondary objectives of the trial |
- ANALIZAR LAS CARGAS VIRALES EN SEMEN
- MEDIR LA CONCENTRACIÓN DE ETRAVIRINA EN SANGRE
- ANALIZAR LA CORRELACIÓN ENTRE NIVLELES PLASMÁTICOS DE ETRAVIRINA Y CARGA VIRAL VIH EN SANGRE Y SEMEN |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.INFECCIÓN DOCUMENTADA POR EL VIH
2. TRATAMIENTO ANTIRETROVIRAL (TARGA) QUE INCLUYA ETRAVIRINA COMO PARTE DEL ESQUEMA DURANTE AL MENOS 4 SEMANAS
3. MAYOR O IGUAL DE 18 AÑOS
4. ACEPTACIÓN Y FIRMA DEL CONSENTIMIENTO INFORMADO |
|
E.4 | Principal exclusion criteria |
1. ESTAR PARTICIPANDO EN ALGÚN ENSAYO CLÍNICO
2. CIFRAS DE ALT > 5 VECES EL LÍMITE SUPERIOR NORMAL
3.SOSPECHA CLINICA DE CIRROSIS HEPÁTICA
4. INSUFICIENCIA RENAL CON CIFRAS DE ACLARAMIENTO DE CREATININA < 50 ML/MIN
5. HEMOGLOBINA <9 G/DL
6. RECUENTO DE POLIMORFONUCLEARES NEUTRÓFILOS < 1000/ML
7. RECUENTO DE PLAQUETAS < 30.000 /MM3
8. EVIDENCIA CLÍNICA O DE LABORATORIO DE INFECCIÓN GENITOURINARIA ACTIVA |
|
E.5 End points |
E.5.1 | Primary end point(s) |
CONCENTRACION FARMACOLOGICA DE ETRAVIRINA EN SEMEN Y PLASMA |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
COMPARAR LOS NIVELES DE ETRAVIRINA EN PLASMA Y SEMEN DE PACIENTES QUE LLEVEN UN MÍNIMO DE 4 SEMANAS DE TRATAMIENTO |
|
E.5.2 | Secondary end point(s) |
- Analizar las cargas virales en semen.
-Medir la concentración de Etravirina en sangre.
-Analizar la correlación entre niveles plasmáticos de Etravirina, y la carga viral VIH
en sangre y semen. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
COMPARAR LOS NIVELES DE ETRAVIRINA EN PLASMA Y SEMEN DE PACIENTES QUE LLEVEN UN MÍNIMO DE 4 SEMANAS DE TRATAMIENTO |
|
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 | 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 |
ANALIZAR LA CONCENTRACIÓN DE ETRAVIRINA Y CARGA VIRAL EN RESERVORIOS (SEMEN) |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
FIN DE ESTUDIO LA ÚLTIMA VISITA DEL ÚLTIMO PACIENTE |
|
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |