Status:
COMPLETED
A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
Human Immunodeficiency Virus-1
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
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 resu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00827112
Start Date
March 1 2009
End Date
July 1 2011
Last Update
June 15 2012
Active Locations (39)
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1
Pfizer Investigational Site
Los Angeles, California, United States, 90027
2
Pfizer Investigational Site
Los Angeles, California, United States, 90028
3
Pfizer Investigational Site
Los Angeles, California, United States, 90048
4
Pfizer Investigational Site
Los Angeles, California, United States, 90069