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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00054717 |
Purpose
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tipranavir Drug: Ritonavir(r) Drug: Comparitor Protease Inhibitor (CPI) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients. |
| Enrollment: | 630 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Tipranavir(TPV)/low dose ritonavir(r) | Drug: Tipranavir Drug: Ritonavir(r) |
| Comparitor protease inhibitor(CPI)/low dose ritonavir(r) | Drug: Ritonavir(r) Drug: Comparitor Protease Inhibitor (CPI) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients meeting the following criteria will be eligible for participation in th is study:
30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.
3. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.
4. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.
Exclusion criteria:
Patients with any of the following criteria are excluded from participation in t he study:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| 1182.12.62 Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| 1182.12.108 El Rio SIA | |
| Tucson, Arizona, United States | |
| United States, California | |
| 1182.12.53 Boehringer Ingelheim Investigational Site | |
| San Francisco, California, United States | |
| 1182.12.59 David Geffen School of Medicine at UCLA | |
| Los Angeles, California, United States | |
| 1182.12.1 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1182.12.5 Boehringer Ingelheim Investigational Site | |
| San Francisco, California, United States | |
| 1182.12.9 Boehringer Ingelheim Investigational Site | |
| Berkeley, California, United States | |
| 1182.12.89 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 1182.12.23 Boehringer Ingelheim Investigational Site | |
| Beverly Hills, California, United States | |
| 1182.12.25 Boehringer Ingelheim Investigational Site | |
| San Francisco, California, United States | |
| 1182.12.69 UC Davis Medical Center | |
| Sacramento, California, United States | |
| 1182.12.76 Boehringer Ingelheim Investigational Site | |
| Long Beach, California, United States | |
| 1182.12.82 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1182.12.12 Boehringer Ingelheim Investigational Site | |
| Fountain Valley, California, United States | |
| 1182.12.97 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1182.12.99 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| United States, Colorado | |
| 1182.12.98 University of Colorado Health Sciences Center | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| 1182.12.7 Boehringer Ingelheim Investigational Site | |
| Norwalk, Connecticut, United States | |
| United States, District of Columbia | |
| 1182.12.103 Boehringer Ingelheim Investigational Site | |
| Washington, District of Columbia, United States | |
| 1182.12.70 | |
| Washington, District of Columbia, United States | |
| 1182.12.52 Boehringer Ingelheim Investigational Site | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| 1182.12.45 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 1182.12.79 Boehringer Ingelheim Investigational Site | |
| Fort Lauderdale, Florida, United States | |
| 1182.12.63 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 1182.12.67 Boehringer Ingelheim Investigational Site | |
| Vero Beach, Florida, United States | |
| 1182.12.75 CARES Resource | |
| Miami, Florida, United States | |
| 1182.12.77 Boehringer Ingelheim Investigational Site | |
| Fort Myers, Florida, United States | |
| 1182.12.78 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 1182.12.17 Boehringer Ingelheim Investigational Site | |
| Orlando, Florida, United States | |
| 1182.12.85 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 1182.12.90 Boehringer Ingelheim Investigational Site | |
| Sarasota, Florida, United States | |
| 1182.12.93 Boehringer Ingelheim Investigational Site | |
| Miami Beach, Florida, United States | |
| 1182.12.94 Infectious Disease Research Institute | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| 1182.12.123 Infectious Disease Clinics of Emory | |
| Atlanta, Georgia, United States | |
| 1182.12.72 Boehringer Ingelheim Investigational Site | |
| Decatur, Georgia, United States | |
| 1182.12.88 Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| 1182.12.47 Boehringer Ingelheim Investigational Site | |
| Macon, Georgia, United States | |
| United States, Idaho | |
| 1182.12.8 Family Practice Medical Center | |
| Boise, Idaho, United States | |
| United States, Illinois | |
| 1182.12.49 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| 1182.12.3 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| 1182.12.105 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| 1182.12.48 Boehringer Ingelheim Investigational Site | |
| Indianapolis, Indiana, United States | |
| 1182.12.32 Boehringer Ingelheim Investigational Site | |
| Indianapolis, Indiana, United States | |
| United States, Kentucky | |
| 1182.12.44 Boehringer Ingelheim Investigational Site | |
| Louisville, Kentucky, United States | |
| 1182.12.33 Boehringer Ingelheim Investigational Site | |
| Lexington, Kentucky, United States | |
| United States, Louisiana | |
| 1182.12.95 Boehringer Ingelheim Investigational Site | |
| New Orleans, Louisiana, United States | |
| United States, Maine | |
| 1182.12.81 Boehringer Ingelheim Investigational Site | |
| Portland, Maine, United States | |
| United States, Maryland | |
| 1182.12.6 Boehringer Ingelheim Investigational Site | |
| Bethesda, Maryland, United States | |
| 1182.12.30 Boehringer Ingelheim Investigational Site | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| 1182.12.41 Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| 1182.12.61 Boehringer Ingelheim Investigational Site | |
| Springfield, Massachusetts, United States | |
| 1182.12.100 Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| 1182.12.101 Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| 1182.12.54 Boehringer Ingelheim Investigational Site | |
| Detroit, Michigan, United States | |
| 1182.12.56 Boehringer Ingelheim Investigational Site | |
| Detroit, Michigan, United States | |
| 1182.12.13 University of Michigan Health System | |
| Ann Arbor, Michigan, United States | |
| United States, Minnesota | |
| 1182.12.120 Department of Medicine, HIV/AIDS Program | |
| Minneapolis, Minnesota, United States | |
| United States, Missouri | |
| 1182.12.14 Dybedal Center for Clinical Research | |
| Kansas City, Missouri, United States | |
| 1182.12.87 Boehringer Ingelheim Investigational Site | |
| St Louis, Missouri, United States | |
| United States, Nevada | |
| 1182.12.11 Wellness Center | |
| Las Vegas, Nevada, United States | |
| United States, New Jersey | |
| 1182.12.4 Boehringer Ingelheim Investigational Site | |
| Camden, New Jersey, United States | |
| 1182.12.21 Boehringer Ingelheim Investigational Site | |
| East Orange, New Jersey, United States | |
| United States, New Mexico | |
| 1182.12.40 Boehringer Ingelheim Investigational Site | |
| Santa Fe, New Mexico, United States | |
| United States, New York | |
| 1182.12.36 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1182.12.43 Boehringer Ingelheim Investigational Site | |
| Valhalla, New York, United States | |
| 1182.12.58 Beth Israel Medical Center | |
| New York, New York, United States | |
| 1182.12.119 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1182.12.34 Boehringer Ingelheim Investigational Site | |
| Mount Vernon, New York, United States | |
| 1182.12.68 Boehringer Ingelheim Investigational Site | |
| Albany, New York, United States | |
| 1182.12.83 Boehringer Ingelheim Investigational Site | |
| Stony Brook, New York, United States | |
| 1182.12.96 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1182.12.107 Boehringer Ingelheim Investigational Site | |
| Rochester, New York, United States | |
| 1182.12.22 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| United States, North Carolina | |
| 1182.12.42 Boehringer Ingelheim Investigational Site | |
| Durham, North Carolina, United States | |
| 1182.12.46 Boehringer Ingelheim Investigational Site | |
| Huntersville, North Carolina, United States | |
| United States, Ohio | |
| 1182.12.35 Boehringer Ingelheim Investigational Site | |
| Cleveland, Ohio, United States | |
| 1182.12.24 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 1182.12.65 Ohio State University Medical Center | |
| Columbus, Ohio, United States | |
| 1182.12.109 Boehringer Ingelheim Investigational Site | |
| Akron, Ohio, United States | |
| United States, Oklahoma | |
| 1182.12.80 Infectious Disease Institute Clinical Trials Unit | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| 1182.12.50 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| 1182.12.28 University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| 1182.12.114 Pinnacle Health | |
| Harrisburg, Pennsylvania, United States | |
| United States, Rhode Island | |
| 1182.12.86 The Miriam Hospital | |
| Providence, Rhode Island, United States | |
| United States, South Carolina | |
| 1182.12.10 Boehringer Ingelheim Investigational Site | |
| Columbia, South Carolina, United States | |
| 1182.12.116 Greenville Hospital System | |
| Greenville, South Carolina, United States | |
| United States, Tennessee | |
| 1182.12.2 Boehringer Ingelheim Investigational Site | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| 1182.12.55 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| 1182.12.26 Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| 1182.12.31 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| 1182.12.73 Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| 1182.12.106 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| United States, Virginia | |
| 1182.12.91 Boehringer Ingelheim Investigational Site | |
| Annandale, Virginia, United States | |
| 1182.12.122 VCU Health Systems | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| 1182.12.15 Boehringer Ingelheim Investigational Site | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| 1182.12.29 Boehringer Ingelheim Investigational Site | |
| Milwaukee, Wisconsin, United States | |
| Australia, New South Wales | |
| 1182.12.1401 St. Vincent's Hospital | |
| Darlinghurst, New South Wales, Australia | |
| 1182.12.1403 Albion Street Centre | |
| Surry Hills, New South Wales, Australia | |
| 1182.12.1405 AIDS Research Initiative / Ground Zero | |
| Darlinghurst, New South Wales, Australia | |
| 1182.12.1408 407 Doctors Pty Ltd. | |
| Darlinghurst, New South Wales, Australia | |
| 1182.12.1407 Holdsworth House General Practice | |
| Darlinghurst, New South Wales, Australia | |
| Australia, Queensland | |
| 1182.12.1406 Gold Coast Sexual Health Clinic | |
| Miami, Queensland, Australia | |
| Australia, Victoria | |
| 1182.12.1404 Alfred Hospital | |
| Melbourne, Victoria, Australia | |
| Canada, British Columbia | |
| 1182.12.11002 Boehringer Ingelheim Investigational Site | |
| Vancouver, British Columbia, Canada | |
| Canada, Manitoba | |
| 1182.12.11010 Boehringer Ingelheim Investigational Site | |
| Winnipeg, Manitoba, Canada | |
| Canada, Nova Scotia | |
| 1182.12.11016 Boehringer Ingelheim Investigational Site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| 1182.12.11001 Boehringer Ingelheim Investigational Site | |
| Ottawa, Ontario, Canada | |
| 1182.12.11009 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| 1182.12.11006 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| 1182.12.11004 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| 1182.12.11012 Boehringer Ingelheim Investigational Site | |
| Hamilton, Ontario, Canada | |
| 1182.12.11014 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| 1182.12.11015 Boehringer Ingelheim Investigational Site | |
| Monteal, Quebec, Canada | |
| 1182.12.11003 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| 1182.12.11007 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| 1182.12.11013 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| Puerto Rico | |
| 1182.12.60 Boehringer Ingelheim Investigational Site | |
| Santurce, Puerto Rico | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1182.12 |
| Study First Received: | February 7, 2003 |
| Results First Received: | September 9, 2009 |
| Last Updated: | November 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00054717 History of Changes |
| Health Authority: | Australia: Responsilble Ethics Committee; Canada: Health Canada (TPD); United States: Food and Drug Administration |
|
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Tipranavir Protease Inhibitors Virus Diseases Anti-Retroviral Agents Ritonavir HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |