Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
NCT ID: NCT01332227
Last Updated: 2015-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2011-10-31
2014-02-28
Brief Summary
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Detailed Description
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Intervention model: Parallel versus comparator
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
Raltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference
Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Interventions
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Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks
Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks
Raltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Virologic suppression (HIV-1 RNA \<50 c/mL) for at least 3 months immediately prior to screening
* Virologic suppression (HIV-1 RNA \<40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
* Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent
Exclusion Criteria
* History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
* History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
* Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
* Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Mayers Squibb
Role: STUDY_DIRECTOR
Bristol-Mayers Squibb
Locations
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Health For Life Clinic Pllc
Little Rock, Arkansas, United States
Eisenhower Medical Center
Palm Springs, California, United States
Metropolis Medical Pc
San Francisco, California, United States
Consultive Medicine
Daytona Beach, Florida, United States
Orange County Health Dept.
Orlando, Florida, United States
Triple O Medical Services, P.A.
West Palm Beach, Florida, United States
The Research Institute
Springfield, Massachusetts, United States
Aids Care
Rochester, New York, United States
Local Institution
Paris, Cedex 12, France
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Lyon, , France
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Orléans, , France
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Paris, , France
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Paris, , France
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Strasbourg, , France
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Bochum, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Hamburg, , Germany
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Munich, , Germany
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Genova, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Roma, , Italy
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Warsaw, , Poland
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Wroclaw, , Poland
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Alicante, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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London, Greater London, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Brighton, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Sheffield, , United Kingdom
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2009-017032-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI424-402
Identifier Type: -
Identifier Source: org_study_id
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