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Study investigating a new medicine - MK-1439 in patients diagnosed with HIV-1 without previous treatment for this disease. The study has 2 parts and neither the doctor or patient will know the treatme...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-001573-93

Study investigating a new medicine - MK-1439 in patients diagnosed with HIV-1 without previous treatment for this disease. The study has 2 parts and neither the doctor or patient will know the treatment group. All the patients will be treated with Truvada, some of the patients will be treated in addition with MK-1439, while the others will be treated in addition with Efavirenz. Estudio de búsqueda de un nuevo medicamento -MK-1439 en pacientes infectados por el VIH-1 sin tratamiento previo de esta enfermedad. El estudio tiene consta de dos partes, ni el doctor ni el paciente conocerán el grupo de tratamiento. Todos los pacientes serán tratados con TRUVADA, algunos de ellos serán tratados adicionalmente con MK-1439, mientras que otros lo serán con Efavirenz

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Extrait

Part I 1. Objective: Evaluate the safety and tolerability of MK-1439, at the studied doses, compared to efavirenz, each in combination with TRUVADA® for 24 weeks. 2. Objective: Evaluate the antiretroviral activity of MK-1439, at the studied doses, compared to efavirenz, each in combination with TRUVADA® for 24 weeks, as measured by the proportion of patients with HIV RNA <40 copies/mL at Week 24. Part I and Part II Combined 1. Objective: Evaluate the safety and tolerability of MK-1439, at the final selected dose, compared to efavirenz, each in combination with TRUVADA® for 24 weeks. 2. Objective: Evaluate the central nervous system adverse events (CNS events) associated with the use of the final selected dose of MK-1439 compared with efavirenz, each in combination with TRUVADA® as measured by the proportion of patients with CNS events by Week 8 and by Week 24. Parte I. 1. Objetivo: Evaluar la seguridad y la tolerabilidad de MK-1439, en las dosis estudiadas, comparado con efavirenz, siempre en asociación con TRUVADA®, durante 24 semanas. 2. Objetivo: Evaluar la actividad antirretroviral de MK-1439, en las dosis estudiadas, comparado con efavirenz, siempre en asociación con TRUVADA®, durante 24 semanas, a juzgar por el porcentaje de pacientes con ARN del VIH < 40 copias/ml en la semana 24.

Critère d'inclusion

  • Human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral naïve HIV-infected patients,Virus de la inmunodeficiencia humana de tipo 1 (VIH-1), en pacientes infectados por el VIH, sin tratamiento antirretroviral previo

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