Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects
NCT ID: NCT00197145
Last Updated: 2018-11-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
24 participants
INTERVENTIONAL
2005-07-21
2007-09-11
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
Study Groups
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GW873140
GW873140
400 mg twice daily
Interventions
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GW873140
400 mg twice daily
Eligibility Criteria
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Inclusion Criteria
* Screening viral load at least 5000copies/mL.
* R5-tropic only virus at screening.
* Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI).
* Stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
* Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
* Women of childbearing potential must use specific forms of contraception.
Exclusion Criteria
* History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
* R5/X4-tropic, X4-tropic only, or non-phenotypeable virus at screening.
* Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
* Pregnancy or breastfeeding women.
* Recent participation in an experimental drug trial.
* Prior use of a CCR5 or CXCR4 antagonist.
* Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
* Current use of certain medications may exclude participation in this study.
* Additional qualifying criteria and laboratory test requirements to be assessed by study physician.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Laguna Beach, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Tarzana, California, United States
GSK Investigational Site
Glastonbury, Connecticut, United States
GSK Investigational Site
Norwalk, Connecticut, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
GSK Investigational Site
Fort Myers, Florida, United States
GSK Investigational Site
Key West, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Oakland Park, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Plantation, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Portland, Maine, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
East Orange, New Jersey, United States
GSK Investigational Site
Hillsborough, New Jersey, United States
GSK Investigational Site
Newark, New Jersey, United States
GSK Investigational Site
Mount Vernon, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Akron, Ohio, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Columbia, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Annandale, Virginia, United States
GSK Investigational Site
Hampton, Virginia, United States
GSK Investigational Site
Lynchburg, Virginia, United States
GSK Investigational Site
Spokane, Washington, United States
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Ponce, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
Countries
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Other Identifiers
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CCR102709
Identifier Type: -
Identifier Source: org_study_id
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