GW873140 In Combination With Kaletra In HIV Infected Subjects
NCT ID: NCT00102778
Last Updated: 2017-05-30
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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TERMINATED
PHASE2
175 participants
INTERVENTIONAL
2004-12-31
2007-09-30
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
Interventions
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GW873140
Kaletra (lopinavir/ritonavir)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females must be of either non-childbearing age, or have a negative pregnancy test.
* All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
* Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
* Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.
* Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).
* Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.
* Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.
* Signed and dated written informed consent prior to study entry.
Exclusion Criteria
* No active Class C AIDS-defining illness.
* No laboratory abnormalities at screen.
* No significant blood loss prior to study start.
* No pregnant or breastfeeding women.
* Additional qualifying criteria to be determined by the physician.
18 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Fountain Valley, 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
San Francisco, California, United States
GSK Investigational Site
Denver, Colorado, 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
Bradenton, Florida, 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
Orlando, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Jackson, Mississippi, United States
GSK Investigational Site
Santa Fe, New Mexico, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Allentown, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Hampton, Virginia, United States
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Hamilton, Ontario, Canada
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Sainte-Foy, Quebec, Canada
GSK Investigational Site
Copenhagen, , Denmark
GSK Investigational Site
Hvidovre, , Denmark
GSK Investigational Site
Le Kremlin-Bicêtre, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
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Paris, , France
GSK Investigational Site
Saint-Denis, , France
GSK Investigational Site
Tourcoing, , France
GSK Investigational Site
Villejuif, , France
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Turin, Piedmont, Italy
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Cascais, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Manchester, Lancashire, United Kingdom
GSK Investigational Site
Brighton, Sussex East, United Kingdom
GSK Investigational Site
Birmingham, Warwickshire, United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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100136
Identifier Type: -
Identifier Source: org_study_id
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