E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophilaxis VIH infecction post accidental exposition (PPE) |
proxilaxis HIV post exposición accidental |
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E.1.1.1 | Medical condition in easily understood language |
prevenction VIH |
prevención infección HIV |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020160 |
E.1.2 | Term | HIV disease |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Compare the rate of dropouts from a new pattern of prophylaxis (PEP) post-exposure HIV with a guideline classic 28 days of treatment. |
Comparar la tasa de abandonos de una nueva pauta de profilaxis post-exposición (PEP) al VIH con una pauta clásica de 28 días de tratamiento. |
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E.2.2 | Secondary objectives of the trial |
• Compare the tolerability of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up. • Compare the adherence to the treatment of a new pattern of prophylaxis post-exposure (PEP) HIV with a classic pattern during the 28 days of treatment. • Compare the rate of seroconversion of a new pattern of prophylaxis (PEP) post-exposure HIV with a classic pattern at 24 weeks of follow-up |
• Comparar la tolerabilidad de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a las 24 semanas de seguimiento. • Comparar la adherencia al tratamiento de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a los 28 días de tratamiento. • Comparar la tasa de seroconversión de una nueva pauta de tratamiento de profilaxis post-exposición (PEP) al VIH con una pauta clásica a las 24 semanas de seguimiento
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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 |
Title: An open, randomized, clinical controlled assay to study the pharmacokinetics and effects on immune system homeostasis of Elvitegravir in patients non-infected with HIV during post-exposure prophylaxis (PEP). STRIBPEP/PK. v 1.0 (20/03/2014) |
TÍTULO: Estudio para evaluar la Farmacocinética y los efectos sobre la homeostasis del sistema inmune del Elvitegravir (Stribild®) en pacientes no infectados por el VIH durante la Profilaxis Post-Exposición: ensayo clínico controlado, abierto, con asignación aleatoria (subestudio del estudio STRIB-PEP/pk).v 1.0 (20/03/2014) |
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E.3 | Principal inclusion criteria |
1. equal to or more than 18 years old. 2 have suffered exposure to HIV, not occupational , and which meets the requirements of the current recommendations to initiate PEP with three antiretroviral drugs. 3 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails. |
1. Edad igual o superior a 18 años. 2. Haber sufrido exposición al VIH, no ocupacional , y que cumpla los requisitos de las recomendaciones actuales para iniciar PEP con tres fármacos antirretrovirales. 3. Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta.
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E.4 | Principal exclusion criteria |
1 pregnant women, nursing mothers, or those who intend to become pregnant during the study period. 2. subjects that is known or suspected that the source case presented resistance to any of the guidelines of the study drugs. 3. treatment with drugs that are contraindicated with the study, or products under investigation. |
1. Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio. 2. Sujetos en los que se conozca o sospeche que el caso fuente presenta resistencias a alguno de los fármacos de las pautas del estudio. 3. Tratamiento con fármacos contraindicados con los del estudio, o productos en fase de investigación.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint Proportion of patients who leave the initial treatment of prophylaxis post-exposure (PEP) to HIV for any reason within 28 days of treatment.
A subject is considered that he leaves treatment before 28 days if: 1. die 2. do not go to visit from week 4 3 change or stop treatment in study |
Variable principal Proporción de pacientes que abandonan el tratamiento inicial de profilaxis post-exposición (PEP) al VIH por cualquier motivo antes de 28 días de tratamiento.
Un sujeto se considera que abandona el tratamiento si antes de los 28 días: 1. muere 2. no acude a la visita de la semana 4 3. cambia o suspende el tratamiento en estudio
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Incidence of adverse clinical events I laboratory abnormalities. • Proportion of patients who discontinued treatment toxicity or intolerance in each of the branches of the 24 weeks of follow-up treatment. • Degree of adherence (measured by counting tablets and adherence of the patient questionnaire) during the treatment period. • Time to loss of adherence to art. • Proportion of patients with seroconversion in both branches of treatment at 24 weeks of follow-up. |
• 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 (medido mediante recuento de comprimidos y cuestionario de adherencia del paciente) 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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.8.5 | 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |