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
πΊπΈLos Angeles, California, United States
Univ of Miami School of Medicine
πΊπΈMiami, Florida, United States
Northwestern Univ / Div of Infect Diseases
πΊπΈChicago, Illinois, United States
Chase Braxton Health Service
πΊπΈBaltimore, Maryland, United States
Beth Israel Deaconess Med Ctr
πΊπΈBoston, Massachusetts, United States
Albany Med College
πΊπΈAlbany, New York, United States
Univ of North Carolina / Infectious Disease Division
πΊπΈChapel Hill, North Carolina, United States
The Research and Education Group
πΊπΈPortland, Oregon, United States
LAC / USC Med Ctr / Infectious DiseasesπΊπΈLos Angeles, California, United States