Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
NCT ID: NCT00634959
Last Updated: 2010-11-10
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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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2003-07-31
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Maraviroc (UK-427,857)
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
2
Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
3
Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
4
Maraviroc (UK-427,857)
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
5
Placebo
Matching placebo oral tablet on Days 1-10 (fed and fasted)
Interventions
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Maraviroc (UK-427,857)
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
Maraviroc (UK-427,857)
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
Placebo
Matching placebo oral tablet on Days 1-10 (fed and fasted)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight between 50 and 100kg and within the permitted range for their height
* Patients with virus that targets CCR5 receptor
Exclusion Criteria
* Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
* Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
* Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit
18 Years
55 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Cologne, , Germany
Pfizer Investigational Site
Frankfurt, , Germany
Pfizer Investigational Site
Hamburg, , Germany
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
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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A4001015
Identifier Type: -
Identifier Source: org_study_id