Conditions: HIV-1
Keywords: Double-blind comparative trial maraviroc versus emtricitabine/tenofovir both with darunavir/ritonavir antiretroviral-naive Ccr5 tropic Hiv 1 patients.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 813
Healthy volunteers: no

Brief summary:
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.

Detailed description:
The study was terminated on October 8, 2013 following a preliminary review of the Week 48 primary efficacy data by the study's external independent Data Monitoring Committee (DMC). The DMC assessed the data as demonstrating significant differences between the treatment arms in virologic responses and failures. The DMC recommended and the Sponsor concurred that the study be terminated because of the inferior efficacy of the Maraviroc arm as compared to the comparator arm (Emtricitabine/Tenofovir).

Arms:
arm 1: Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. arm 2: Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.

Interventions: intervention 1: Maraviroc intervention 2: Emtricitabine/tenofovir intervention 3: darunavir/ritonavir 800/100 mg intervention 4: placebo for emtricitabine/tenofovir intervention 5: placebo for maraviroc
Intervention descriptions: intervention 1: Maraviroc tablet 150 mg once daily for 96 weeks. intervention 2: Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks. intervention 3: darunavir/ritonavir 800/100 mg intervention 4: placebo for emtricitabine/tenofovir intervention 5: placebo for maraviroc

Protocol document: