Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
NCT ID: NCT00298350
Last Updated: 2008-07-29
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
278 participants
INTERVENTIONAL
2006-02-28
2007-07-31
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
QUADRUPLE
Interventions
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GS-9137 - A Novel HIV-1 Integrase Inhibitor
Eligibility Criteria
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Inclusion Criteria
* Failed/Failing protease inhibitor based antiretroviral therapy.
* Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
* Negative Serum Pregnancy Test.
* GFR by Cockcroft Gault greater than or equal to 80 mL/min.
* AST \& ALT less than or equal to 2.5x ULN.
* Total Bilirubin less than or equal to 1.5 mg/dL.
* Albumin greater than 3.5 mg/dL.
* Prothrombin Time INR 1.0-1.4
* Platelets greater than or equal to 50,000.
* Hemoglobin greater than or equal to 8.0 mg/dL.
* Absolute Neutrophil Count greater than or equal to 1000.
Exclusion Criteria
* Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
* Ascites or encephalopathy.
* Breast Feeding.
* Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences INC
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Fountain Valley, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Oakland, California, United States
San Diego, California, United States
San Francisco, California, United States
Stanford, California, United States
Sunnyvale, California, United States
Torrance, California, United States
Denver, Colorado, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Atlantis, Florida, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
North Palm Beach, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Henderson, Nevada, United States
Hillsborough, New Jersey, United States
Santa Fe, New Mexico, United States
Albany, New York, United States
Manhasset, New York, United States
New York, New York, United States
Huntersville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Annandale, Virginia, United States
Hampton, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
San Juan, , Puerto Rico
Santurce, , Puerto Rico
Countries
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References
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Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, Kearney BP, Cheng AK. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.
Related Links
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Gilead Website
Other Identifiers
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GS-US-183-0105
Identifier Type: -
Identifier Source: org_study_id
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