GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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 virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00105079

Run by

Hoffmann-La Roche

People needed

337

Starts

2005-04-01

Expected to finish

2008-07-01

Last updated by the study team

2011-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Hobson City, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Berkeley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Ypsilanti, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Huntersville, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Hamilton, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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