E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV- post exposition prophylaxis |
profilaxis post-exposición VIH |
|
E.1.1.1 | Medical condition in easily understood language |
Treatment after exposure to HIV |
Tratamiento tras exposición frente al VIH |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 |
To compare the tolerability and patient adherence of two antiretroviral regimens in HIV Post-exposure Prophylaxis: Truvada® + Raltegravir vs. Truvada® + Lopinavir/ritonavir. |
Comparar la tolerabilidad y la adherencia de dos pautas de tratamiento de profilaxis post-exposición (PEP) al VIH: Truvada® + Raltegravir vs. Truvada® + Lopinavir/ritonavir. |
|
E.2.2 | Secondary objectives of the trial |
- To compare drop-outs rate - To compare the tolerability of a new regimen - To compare adherence to antiretroviral treatment - To compare HIV seroconversion |
- Comparar la tasa de abandonos entre ambas pautas - Comparar la tolerabilidad de una nueva pauta - Comparar la adherencia al tratamiento entre ambas pautas - Comparar la tasa de seroconversión entre ambas pautas |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
?Pharmacokinetic study and effects on homeostasis in two antiretroviral regimens in HIV Post-exposure Prophylaxis? 1.0 of 2011-08-02 Objective: to evaluate pharmacokinetics and effects on blood and mucosa homeostasis. |
"Estudio para evaluar la Farmacocinética y los efectos sobre la homeostasis del sistema inmune en pacientes no infectados por el VIH durante la Profilaxis Post-Exposición." Versión 1.0, 02 de agosto de 2011. Objetivo: evaluar la farmacocinética y los efectos del raltegravir sobre la homeostasis del sistema inmune en sangre y mucosas |
|
E.3 | Principal inclusion criteria |
- 18 years or older - HIV exposure requiring prophylaxis under current guidelines |
- Edad igual o superior a 18 años. - Haber sufrido exposición al VIH, ocupacional o no, y que cumpla los requisitos de las recomendaciones actuales para iniciar PEP |
|
E.4 | Principal exclusion criteria |
- Pregnancy, nursing, or planned pregnancy during the study period - Suspected drug resistance in source case - Contraindications to the study drugs |
- Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio. - Sujetos en los que se conozca o sospeche que el caso fuente presenta resistencias a alguno de los fármacos de las pautas del estudio. - Tratamiento con fármacos contraindicados con los del estudio, o productos en fase de investigación. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Proportion of patients droping-out before completing 28-days antiretroviral treatment |
- Proporción de pacientes que abandonan el tratamiento antes de los 28 días |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Incidence of adverse effects (clinical and laboratory) during antiretroviral treatment - Proportion of patients discontinuing antiretroviral regimen due to toxicity - Adherence to antiretroviral treatment - Time to adherence loss - Proportion of HIV-seropositive at 24 weeks |
- Incidencia de acontecimientos adversos clínicos y/o alteraciones de laboratorio. -Proporción de pacientes que discontinúan el tratamiento por toxicidad o intolerancia en cada una de las ramas de tratamiento a las 24 semanas de seguimiento. - Grado de adherencia durante el periodo de tratamiento. - Tiempo hasta la pérdida de adherencia al TARV. - Proporción de pacientes con seroconversión en ambas ramas de tratamiento a las 24 semanas de seguimiento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
28 days and 24 weeks |
28 días y 2 semanas |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
last visit of hte last subject |
última visita del último sujeto |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 1 |
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 |