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A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients - NCT00827112-60657(Clinical Trial 265074)



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City:  Chicago
State:  
IL
Zip Code: 60657
Conditions: Human Immunodeficiency Virus-1
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit. - CD4 count ≥100 cells/mm3 at Screening. - Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity. Exclusion Criteria: - Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time. - Any evidence of resistance to atazanavir, tenofovir, and emtricitabine. - X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.
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Data Source: ClinicalTrials.gov
Date Processed: September 9, 2010
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