Resumen

Proporcionar acceso a maraviroc a pacientes que tienen opciones terapéuticas limitadas o inexistentes y recopilar más datos de seguridad en una población de pacientes más amplia.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.

Criterios de exclusión

Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials

Intervenciones

drug

maraviroc

The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Ubicaciones

Fundacion Huesped, Departamento de Investigacion Clinica

Buenos Aires, Argentina

FUNCEI