Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00054717
First received: February 7, 2003
Last updated: May 18, 2012
Last verified: May 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Treatment Response at Week 48 [ Time Frame: At week 48 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
Secondary Outcome Measures:
- Treatment Response at Week 24 [ Time Frame: Week 24 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 2 [ Time Frame: week 2 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 4 [ Time Frame: week 4 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 8 [ Time Frame: week 8 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 16 [ Time Frame: week 16 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 24 [ Time Frame: week 24 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 32 [ Time Frame: Week 32 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 40 [ Time Frame: Week 40 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 48 [ Time Frame: Week 48 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 56 [ Time Frame: week 56 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 64 [ Time Frame: week 64 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 72 [ Time Frame: Week 72 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 80 [ Time Frame: Week 80 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 88 [ Time Frame: Week 88 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Treatment Response at Week 96 [ Time Frame: Week 96 ]Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
- Time to Treatment Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
- Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
- Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
- Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ]Viral Load (VL) >= 1 log reduction from baseline
- Virologic Response at Week 2 [ Time Frame: Week 2 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 4 [ Time Frame: Week 4 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 8 [ Time Frame: Week 8 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 16 [ Time Frame: Week 16 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 24 [ Time Frame: Week 24 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 32 [ Time Frame: Week 32 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 40 [ Time Frame: Week 40 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 48 [ Time Frame: Week 48 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 56 [ Time Frame: Week 56 ]VL >= 1 log reduction from baseline
- Virologic Response at Week 64 [ Time Frame: Week 64 ]VL >= 1 log reduction from baseline
- Median Change From Baseline in Viral Load to Week 2 [ Time Frame: Baseline to Week 2 ]
- Median Change From Baseline in Viral Load to Week 4 [ Time Frame: Baseline to Week 4 ]
- Median Change From Baseline in Viral Load to Week 8 [ Time Frame: Baseline to Week 8 ]
- Median Change From Baseline in Viral Load to Week 16 [ Time Frame: Baseline to Week 16 ]
- Median Change From Baseline in Viral Load to Week 24 [ Time Frame: Baseline to Week 24 ]
- Median Change From Baseline in Viral Load to Week 32 [ Time Frame: Baseline to Week 32 ]
- Median Change From Baseline in Viral Load to Week 40 [ Time Frame: Baseline to Week 40 ]
- Median Change From Baseline in Viral Load to Week 48 [ Time Frame: Baseline to Week 48 ]
- Median Change From Baseline in Viral Load to Week 56 [ Time Frame: Baseline to Week 56 ]
- Median Change From Baseline in Viral Load to Week 64 [ Time Frame: Baseline to Week 64 ]
- Median Change From Baseline in Viral Load to Week 72 [ Time Frame: Baseline to Week 72 ]
- Median Change From Baseline in Viral Load to Week 80 [ Time Frame: Baseline to Week 80 ]
- Median Change From Baseline in Viral Load to Week 88 [ Time Frame: Baseline to Week 88 ]
- Median Change From Baseline in Viral Load to Week 96 [ Time Frame: Baseline to Week 96 ]
- Mean Change From Baseline to Week 2 in CD4+ Cell Count [ Time Frame: Baseline to Week 2 ]
- Mean Change From Baseline to Week 4 in CD4+ Cell Count [ Time Frame: Baseline to Week 4 ]
- Mean Change From Baseline to Week 16 in CD4+ Cell Count [ Time Frame: Baseline to Week 16 ]
- Mean Change From Baseline to Week 24 in CD4+ Cell Count [ Time Frame: Baseline to Week 24 ]
- Mean Change From Baseline to Week 32 in CD4+ Cell Count [ Time Frame: Baseline to Week 32 ]
- Mean Change From Baseline to Week 40 in CD4+ Cell Count [ Time Frame: Baseline to Week 40 ]
- Mean Change From Baseline to Week 48 in CD4+ Cell Count [ Time Frame: Baseline to Week 48 ]
- Mean Change From Baseline to Week 56 in CD4+ Cell Count [ Time Frame: Baseline to Week 56 ]
- Mean Change From Baseline to Week 64 in CD4+ Cell Count [ Time Frame: Baseline to Week 64 ]
- Mean Change From Baseline to Week 72 in CD4+ Cell Count [ Time Frame: Baseline to Week 72 ]
- Mean Change From Baseline to Week 80 in CD4+ Cell Count [ Time Frame: Baseline to Week 80 ]
- Mean Change From Baseline to Week 88 in CD4+ Cell Count [ Time Frame: Baseline to Week 88 ]
- Mean Change From Baseline to Week 96 in CD4+ Cell Count [ Time Frame: Baseline to Week 96 ]
- Time to New CDC Class C Progression Event or Death. [ Time Frame: after 48 weeks of treatment ]23 patients in the TPV/r group and 16 patients in the CPI/r group.
- Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ]Viral Load < 400 copies/mL
- Virologic Response at Week 2 [ Time Frame: Week 2 ]Viral Load < 400 copies/mL
- Virologic Response at Week 4 [ Time Frame: Week 4 ]Viral Load < 400 copies/mL
- Virologic Response at Week 8 [ Time Frame: Week 8 ]Viral Load < 400 copies/mL
- Virologic Response at Week 16 [ Time Frame: Week 16 ]Viral Load < 400 copies/mL
- Virologic Response at Week 24 [ Time Frame: Week 24 ]Viral Load < 400 copies/mL
- Virologic Response at Week 32 [ Time Frame: week 32 ]Viral Load < 400 copies/mL
- Virologic Response at Week 40 [ Time Frame: Week 40 ]Viral Load < 400 copies/mL
- Virologic Response at Week 48 [ Time Frame: Week 48 ]Viral Load < 400 copies/mL
- Virologic Response at Week 56 [ Time Frame: Week 56 ]Viral Load < 400 copies/mL
- Virologic Response at Week 64 [ Time Frame: Week 64 ]Viral Load < 400 copies/mL
- Virologic Response at Week 72 [ Time Frame: Week 72 ]Viral Load < 400 copies/mL
- Virologic Response at Week 80 [ Time Frame: Week 80 ]Viral Load < 400 copies/mL
- Virologic Response at Week 88 [ Time Frame: week 88 ]Viral Load < 400 copies/mL
- Virologic Response at Week 96 [ Time Frame: week 96 ]Viral Load < 400 copies/mL
- Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ]Viral Load < 50 copies/mL
- Virologic Response at Week 2 [ Time Frame: Week 2 ]Viral Load < 50 copies/mL
- Virologic Response at Week 4 [ Time Frame: Week 4 ]Viral Load < 50 copies/mL
- Virologic Response at Week 8 [ Time Frame: Week 8 ]Viral Load < 50 copies/mL
- Virologic Response at Week 16 [ Time Frame: Week 16 ]Viral Load < 50 copies/mL
- Virologic Response at Week 24 [ Time Frame: Week 24 ]Viral Load < 50 copies/mL
- Virologic Response at Week 32 [ Time Frame: Week 32 ]Viral Load < 50 copies/mL
- Virologic Response at Week 40 [ Time Frame: Week 40 ]Viral Load < 50 copies/mL
- Virologic Response at Week 48 [ Time Frame: Week 48 ]Viral Load < 50 copies/mL
- Virologic Response at Week 56 [ Time Frame: Week 56 ]Viral Load < 50 copies/mL
- Virologic Response at Week 64 [ Time Frame: Week 64 ]Viral Load < 50 copies/mL
- Virologic Response at Week 72 [ Time Frame: Week 72 ]Viral Load < 50 copies/mL
- Virologic Response at Week 80 [ Time Frame: Week 80 ]Viral Load < 50 copies/mL
- Virologic Response at Week 88 [ Time Frame: Week 88 ]Viral Load < 50 copies/mL
- Virologic Response at Week 96 [ Time Frame: Week 96 ]Viral Load < 50 copies/mL
| 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 |
Criteria
Inclusion Criteria:
Patients meeting the following criteria will be eligible for participation in th is study:
- Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
- Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites:
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:
- Antiretroviral (ARV) medication naïve.
- Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.
- alanine aminotransferase (ALT) >=3.0x upperlimit of normal (ULN) and aspartate aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(DAIDS) Grade 1) at either screening visit.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054717
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| 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 | |
| 1182.12.9 Boehringer Ingelheim Investigational Site | |
| Berkeley, California, United States | |
| 1182.12.23 Boehringer Ingelheim Investigational Site | |
| Beverly Hills, California, United States | |
| 1182.12.12 Boehringer Ingelheim Investigational Site | |
| Fountain Valley, California, United States | |
| 1182.12.76 Boehringer Ingelheim Investigational Site | |
| Long Beach, 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 | |
| 1182.12.82 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1182.12.97 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1182.12.69 UC Davis Medical Center | |
| Sacramento, California, United States | |
| 1182.12.99 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 1182.12.89 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 1182.12.53 Boehringer Ingelheim Investigational Site | |
| San Francisco, California, United States | |
| 1182.12.25 Boehringer Ingelheim Investigational Site | |
| San Francisco, California, United States | |
| 1182.12.5 Boehringer Ingelheim Investigational Site | |
| San Francisco, 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 | |
| 1182.12.52 Boehringer Ingelheim Investigational Site | |
| Washington, District of Columbia, United States | |
| 1182.12.70 | |
| Washington, District of Columbia, United States | |
| 1182.12.103 Boehringer Ingelheim Investigational Site | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| 1182.12.79 Boehringer Ingelheim Investigational Site | |
| Fort Lauderdale, Florida, United States | |
| 1182.12.77 Boehringer Ingelheim Investigational Site | |
| Fort Myers, Florida, United States | |
| 1182.12.45 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 1182.12.85 Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| 1182.12.75 CARES Resource | |
| Miami, Florida, United States | |
| 1182.12.93 Boehringer Ingelheim Investigational Site | |
| Miami Beach, Florida, United States | |
| 1182.12.17 Boehringer Ingelheim Investigational Site | |
| Orlando, Florida, United States | |
| 1182.12.90 Boehringer Ingelheim Investigational Site | |
| Sarasota, Florida, United States | |
| 1182.12.63 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 1182.12.78 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 1182.12.94 Infectious Disease Research Institute | |
| Tampa, Florida, United States | |
| 1182.12.67 Boehringer Ingelheim Investigational Site | |
| Vero Beach, Florida, United States | |
| United States, Georgia | |
| 1182.12.88 Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| 1182.12.123 Infectious Disease Clinics of Emory | |
| Atlanta, Georgia, United States | |
| 1182.12.72 Boehringer Ingelheim Investigational Site | |
| Decatur, Georgia, United States | |
| 1182.12.47 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 | |
| 1182.12.33 Boehringer Ingelheim Investigational Site | |
| Lexington, Kentucky, United States | |
| 1182.12.44 Boehringer Ingelheim Investigational Site | |
| Louisville, 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 | |
| 1182.12.30 Boehringer Ingelheim Investigational Site | |
| Baltimore, Maryland, United States | |
| 1182.12.6 Boehringer Ingelheim Investigational Site | |
| Bethesda, Maryland, United States | |
| United States, Massachusetts | |
| 1182.12.100 Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| 1182.12.101 Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| 1182.12.41 Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| 1182.12.61 Boehringer Ingelheim Investigational Site | |
| Springfield, Massachusetts, United States | |
| United States, Michigan | |
| 1182.12.13 University of Michigan Health System | |
| Ann Arbor, Michigan, United States | |
| 1182.12.54 Boehringer Ingelheim Investigational Site | |
| Detroit, Michigan, United States | |
| 1182.12.56 Boehringer Ingelheim Investigational Site | |
| Detroit, 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 | |
| 1182.12.68 Boehringer Ingelheim Investigational Site | |
| Albany, New York, United States | |
| 1182.12.34 Boehringer Ingelheim Investigational Site | |
| Mount Vernon, New York, United States | |
| 1182.12.58 Beth Israel Medical Center | |
| New York, New York, United States | |
| 1182.12.22 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1182.12.96 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1182.12.36 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1182.12.119 Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| 1182.12.107 Boehringer Ingelheim Investigational Site | |
| Rochester, New York, United States | |
| 1182.12.83 Boehringer Ingelheim Investigational Site | |
| Stony Brook, New York, United States | |
| 1182.12.43 Boehringer Ingelheim Investigational Site | |
| Valhalla, 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 | |
| 1182.12.109 Boehringer Ingelheim Investigational Site | |
| Akron, Ohio, United States | |
| 1182.12.24 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 1182.12.35 Boehringer Ingelheim Investigational Site | |
| Cleveland, Ohio, United States | |
| 1182.12.65 Ohio State University Medical Center | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| 1182.12.80 Infectious Disease Institute Clinical Trials Unit | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| 1182.12.114 Pinnacle Health | |
| Harrisburg, Pennsylvania, United States | |
| 1182.12.50 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| 1182.12.28 University of Pennsylvania | |
| Philadelphia, 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 | |
| 1182.12.106 Boehringer Ingelheim Investigational Site | |
| Dallas, 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 | |
| 1182.12.26 Boehringer Ingelheim Investigational Site | |
| San Antonio, 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 | |
| 1182.12.1405 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 | |
| 1182.12.1403 Albion Street Centre | |
| Surry Hills, 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 | |
| 1182.12.11012 Boehringer Ingelheim Investigational Site | |
| Hamilton, Ontario, Canada | |
| 1182.12.11001 Boehringer Ingelheim Investigational Site | |
| Ottawa, Ontario, Canada | |
| 1182.12.11004 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| 1182.12.11009 Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| 1182.12.11006 Boehringer Ingelheim Investigational Site | |
| Toronto, 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 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00054717 History of Changes |
| Other Study ID Numbers: | 1182.12 |
| Study First Received: | February 7, 2003 |
| Results First Received: | September 9, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Australia: Responsilble Ethics Committee Canada: Health Canada (TPD) United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Protease Inhibitors |
Ritonavir Tipranavir Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013