GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
NCT ID: NCT00105079
Last Updated: 2011-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
337 participants
INTERVENTIONAL
2005-04-30
2008-07-31
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
NONE
Study Groups
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saquinavir/ritonavir
saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
saquinavir [Invirase]
1000 milligram (mg) Oral (po) twice daily (bid)
Emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
Ritonavir
100 mg po bid
lopinavir/ritonavir
lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Lopinavir/ritonavir
Lopinavir/ritonavir 400/100 mg po bid
Emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
Interventions
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saquinavir [Invirase]
1000 milligram (mg) Oral (po) twice daily (bid)
Lopinavir/ritonavir
Lopinavir/ritonavir 400/100 mg po bid
Emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
Ritonavir
100 mg po bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* chronic HIV-1 infection;
* treatment-naive;
* HIV-1 RNA viral load \>=10,000copies/mL;
* women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days after the last dose of study medication.
Exclusion Criteria
* active hepatitis B infection;
* previous treatment with antiretroviral medication;
* patients who have received an investigational drug within the last 4 weeks.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hobson City, Alabama, United States
Tucson, Arizona, United States
Berkeley, California, United States
Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Ypsilanti, Michigan, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
New York, New York, United States
Huntersville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Avignon, , France
Lyon, , France
Lyon, , France
Marseille, , France
Marseille, , France
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Paris, , France
Rouen, , France
Strasbourg, , France
Suresnes, , France
Toulouse, , France
Tourcoing, , France
Ponce, , Puerto Rico
Bangkok, , Thailand
Countries
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Other Identifiers
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ML18413
Identifier Type: -
Identifier Source: org_study_id