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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
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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham - 1917 Research Clinic
Birmingham, Alabama, United States
Health Services Center
Hobson City, Alabama, United States
Kaiser Permanente
Hayward, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Dr. Anthony Mills, MD, Inc.
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
University of California Davis Research
Sacramento, California, United States
TICON I Research Clinic (DEXA Scan only)
Sacramento, California, United States
Kaiser Hospital Sacramento
Sacramento, California, United States
Start Date
September 1, 2011
Primary Completion Date
August 1, 2013
Completion Date
January 1, 2014
Last Updated
January 14, 2016
813
ACTUAL participants
Maraviroc
DRUG
Emtricitabine/tenofovir
DRUG
darunavir/ritonavir 800/100 mg
DRUG
placebo for emtricitabine/tenofovir
DRUG
placebo for maraviroc
DRUG
Lead Sponsor
ViiV Healthcare
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05668026