GW873140 In Combination With Combivir In HIV Infected Subjects
NCT ID: NCT00104429
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
125 participants
INTERVENTIONAL
2005-01-31
2006-01-31
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
Combivir
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 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
* Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit.
* Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
* Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a 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
* Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit.
* Active Class C AIDS-defining illness.
* Laboratory abnormalities at screen.
* Significant blood loss prior to study start.
* 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
Bakersfield, California, United States
GSK Investigational Site
Beverly Hills, 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
Stanford, California, United States
GSK Investigational Site
Tarzana, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Vero Beach, Florida, United States
GSK Investigational Site
Conyers, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Newark, New Jersey, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Providence, Rhode Island, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Levallois-Perret, , France
GSK Investigational Site
Lyon, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Brescia, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Coimbra, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Porto, , Portugal
GSK Investigational Site
Madrid, , 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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102881
Identifier Type: -
Identifier Source: org_study_id
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