NCT01345630

Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 813 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV-1

Interventions

Type	Name	Description
DRUG	Maraviroc	Maraviroc tablet 150 mg once daily for 96 weeks.
DRUG	Emtricitabine/tenofovir	Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
DRUG	darunavir/ritonavir 800/100 mg	darunavir/ritonavir 800/100 mg
DRUG	placebo for emtricitabine/tenofovir	placebo for emtricitabine/tenofovir
DRUG	placebo for maraviroc	placebo for maraviroc

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-08-01
• Completion: 2014-01-01
• First posted: 2011-05-02
• Last updated: 2016-01-14
• Results posted: 2016-01-14

Locations

177 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom