Clinical Trials Detalhe
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
Visão Geral
Gender
ALL
Idade
N/A
Fase
PHASE3
Tipo de Estudo
INTERVENTIONAL
Localização
Hospital Prof. Doutor Fernando Fonseca E.P.E. (Amadora, Portugal)
Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos (Lisbon, Portugal)
Hospital Sta. Maria (Lisbon, Portugal)
Hospital São João (Porto, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT01345630Sumário
The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.
Condições
HIV-1
Elegibilidade
Inclusion Criteria: * Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit. * CD4 count equal to or greater than 100 cells/mm3 at Screening. * Have only R5 HIV 1 at Screening as verified by a randomized tropism assay. Exclusion Criteria: * Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time. * Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine. * CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.