To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
150 mg, every 12 hours
40 mg every 12 hours
Pacific Oaks Research
Beverly Hills, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Proportion of subjects with viral load below the limit of quantitation
Time frame: 24 weeks
Time to loss of virologic response
Time frame: 48 weeks
Proportion of subjects with viral load below the limit of quantitation at each visit
Time frame: At each visit
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Northwestern University Medical School
Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cornell Clinical Trials Unit - Chelsea Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Baylor College of Medicine
Houston, Texas, United States