3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
- Conditions
- HIV Infections
- Registration Number
- NCT00275444
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Virologic response after 2 weeks of functional monotherapy At week 2
- Secondary Outcome Measures
Name Time Method Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures. Up to 24 weeks
Trial Locations
- Locations (44)
Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
Living Hope Clinical Trials, Inc.
🇺🇸Long Beach, California, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Vincent Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
1501 N.W. 9th Ave
🇺🇸Miami, Florida, United States
Hillsborough County Health Dept.
🇺🇸Tampa, Florida, United States
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
CORE Center
🇺🇸Chicago, Illinois, United States
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