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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: HIV-1

In brief

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.

Key facts

Study ID

NCT01345630

Run by

ViiV Healthcare

People needed

813

Starts

2011-09-01

Expected to finish

2014-01-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Synarc Inc. — San Francisco, California, United States
• Investigational Drugs Pharmacy — San Francisco, California, United States
• Kaiser Permanente - Clinical Trials Unit — San Francisco, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States
• Kaiser Permanente — Union City, California, United States
• University of Colorado Denver - University of Colorado Hospital — Aurora, Colorado, United States
• Kaiser Permanente of Colorado — Denver, Colorado, United States
• Yale - New Haven Hospital Nathan Smith Clinic — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Circle CARE Center — Norwalk, Connecticut, United States
• Capital Medical Associates, PC — Washington D.C., District of Columbia, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Broward Health - Comprehensive Care Center — Fort Lauderdale, Florida, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• The Kinder Medical Group — Miami, Florida, United States
• University of Alabama at Birmingham - 1917 Research Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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