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

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.

Timeline

Start

2011-09

Primary completion

2013-08

Completion

2014-01

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

release “An investigational two drug-regimen of maraviroc dosed once daily, combined with darunavir/ritonavir (DRV/r) showed inferior efficacy compared to emtricitabine/tenofovir (FTC/TDF) with DRV/r” gsk.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Emtricitabine/tenofovir	Unknown	—	—
Subject	Maraviroc	Other / unclassified	150 mg	—
Background	Darunavir	Small molecule	800 mg	—
Background	Ritonavir	Other / unclassified	100 mg	—

Indications

No indication recorded.