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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00827112 |
This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.
Condition | Intervention | Phase |
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Human Immunodeficiency Virus-1 |
Drug: maraviroc |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1 |
Estimated Enrollment: | 88 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
maraviroc 150 mg QD + atazanavir/ritonavir 300/100mg QD
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Drug: maraviroc
maraviroc 150mg QD + Atazanavir/ritonavir (300/100mg) QD
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Arm B: Experimental
atazanavir/ritonavir 300/100 mg QD + emtricitabine/tenofovir 200/300mg QD;
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Drug: maraviroc
atazanavir/ritonavir 300/100 mg QD + emtricitabine/tenofovir 200/300mg QD;
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, California | |
Pfizer Investigational Site | Recruiting |
Los Angeles, California, United States, 90069 | |
Pfizer Investigational Site | Not yet recruiting |
Los Angeles, California, United States, 90028 | |
United States, Connecticut | |
Pfizer Investigational Site | Recruiting |
Norwalk, Connecticut, United States, 06851 | |
United States, District of Columbia | |
Pfizer Investigational Site | Recruiting |
Washington, District of Columbia, United States, 20009 | |
United States, Florida | |
Pfizer Investigational Site | Not yet recruiting |
Orlando, Florida, United States, 32803 | |
Pfizer Investigational Site | Not yet recruiting |
St. Petersburg, Florida, United States, 33713 | |
Pfizer Investigational Site | Recruiting |
Miami, Florida, United States, 33137 | |
Pfizer Investigational Site | Not yet recruiting |
Miami, Florida, United States, 33133 | |
Pfizer Investigational Site | Recruiting |
Fort Lauderdale, Florida, United States, 33306 | |
Pfizer Investigational Site | Recruiting |
Pensacola, Florida, United States, 32504 | |
Pfizer Investigational Site | Not yet recruiting |
Tampa, Florida, United States, 33614 | |
Pfizer Investigational Site | Not yet recruiting |
Wilton Manors, Florida, United States, 33305 | |
United States, Georgia | |
Pfizer Investigational Site | Recruiting |
Atlanta, Georgia, United States, 30312 | |
United States, Illinois | |
Pfizer Investigational Site | Recruiting |
Chicago, Illinois, United States, 60657 | |
United States, Massachusetts | |
Pfizer Investigational Site | Recruiting |
Springfield, Massachusetts, United States, 01107 | |
Pfizer Investigational Site | Not yet recruiting |
Springfield, Massachusetts, United States, 01107 | |
United States, New York | |
Pfizer Investigational Site | Not yet recruiting |
Mt. Vernon, New York, United States, 10550 | |
United States, North Carolina | |
Pfizer Investigational Site | Not yet recruiting |
Huntersville, North Carolina, United States, 28078 | |
United States, Texas | |
Pfizer Investigational Site | Not yet recruiting |
Houston, Texas, United States, 77098 | |
Pfizer Investigational Site | Not yet recruiting |
Dallas, Texas, United States, 75204 | |
United States, Washington | |
Pfizer Investigational Site | Not yet recruiting |
Spokane, Washington, United States, 99204 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4001078 |
Study First Received: | January 21, 2009 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00827112 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CCR5-tropic HIV-1 virus |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases |
Anti-Retroviral Agents Emtricitabine HIV Infections Ritonavir Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Atazanavir Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |