Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
| Status: | Terminated |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | January 2014 |
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.
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).
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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
83
sites
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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University of Miami A private research university with more than 15,000 students from around the...
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New York Medical College The College was founded in 1860 by a group of New...
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Parkland Memorial Hospital As our community's public health system, Parkland is the foundation for a...
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East Lansing, Michigan 48824
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Greenville, North Carolina 27834
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Iowa City, Iowa 52242
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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