Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors
- Conditions
- HIV Infections
- Registration Number
- NCT00002361
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
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
🇺🇸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
LAC / USC Med Ctr / Infectious Diseases🇺🇸Los Angeles, California, United States