The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination containing indinavir and ritonavir to HIV-positive patients who have failed previous treatment with protease inhibitors.
Patients receive indinavir and ritonavir twice daily plus 2 NRTIs (NRTIs are not provided by this study). Physical examinations and laboratory tests, including plasma viral RNA levels and CD4 cell counts, are performed at Day 1 and Weeks 4, 8, 12, 16, 20, and 24 (or at discontinuation). The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety. The proportion of patients achieving plasma viral RNA levels below 50 copies/ml (by UltraSensitive assay) are estimated statistically to determine drug efficacy.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
30
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Northwestern Univ / Div of Infect Diseases
Chicago, Illinois, United States
Chase Braxton Health Service
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Baltimore, Maryland, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Albany Med College
Albany, New York, United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, United States
The Research and Education Group
Portland, Oregon, United States