Status:
COMPLETED
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency ...
Eligibility Criteria
Inclusion
- adult patients \>=18 years of age;
- 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
- females who are pregnant or breastfeeding;
- active hepatitis B infection;
- previous treatment with antiretroviral medication;
- patients who have received an investigational drug within the last 4 weeks.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00105079
Start Date
April 1 2005
End Date
July 1 2008
Last Update
November 2 2011
Active Locations (44)
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1
Hobson City, Alabama, United States, 36201
2
Tucson, Arizona, United States, 85745
3
Berkeley, California, United States, 94705
4
Los Angeles, California, United States, 90028