GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
saquinavir/ritonavir
lopinavir/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.
lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.