Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
NCT ID: NCT00782301
Last Updated: 2012-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2009-03-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Maraviroc
maraviroc
maraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
Etravirine
etravirine
etravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
Interventions
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maraviroc
maraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
etravirine
etravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Documented resistance to an NNRTI as well as documented resistance to another antiretroviral agent.
CCR5 tropic virus detected by the TrofileTM assay.
Exclusion Criteria
Prior treatment with darunavir/ritonavir, raltegravir, or another integrase inhibitor, etravirine, maraviroc or another CCR5 inhibitor for more than 14 days at any time.
Subjects receiving treatment for chronic Hepatitis or the expected need to initiate HCV treatment within 48 weeks of randomization. (Subjects who were previously treated for Hepatitis C are eligible for the study).
AST and/or ALT greater than 5 times the upper limit of normal (ACTG Grade 3).
16 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Safety Harbor, Florida, United States
Pfizer Investigational Site
Wilton Manors, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Mount Vernon, New York, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Bellaire, Texas, United States
Pfizer Investigational Site
Conroe, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Stafford, Texas, United States
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Bydgoszcz, , Poland
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4001080
Identifier Type: -
Identifier Source: org_study_id
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