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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034866 |
Purpose
The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Protease inhibitor tipranavir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-Experienced Subjects. |
| Estimated Enrollment: | 165 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | October 2002 |
This study will be conducted in HIV+, multiple ARV medication experienced patients. All patients must have received treatment from each of three ARV classes: NRTIs, NNRTIs and PIs, have received at least two PI-based ARV regimens (may include the current regimen) with a viral load greater than or equal to 1000 copies/mL at the time of study entry. The two separate PI-based regimens must each have been taken for at least 3 months. At least one resistance-conferring PI-mutation (from a pre-established panel) must be present. Baseline genotypic screening will be performed and will be used in conjunction with ARV medication history to determine new background therapy for each individual subject to use.
Following genotypic screening at baseline, qualifying subjects will be randomized to one of three blinded treatment regimens. Subjects will discontinue their current protease inhibitor and initiate TPV/RTV for 2 weeks of functional monotherapy. Thereafter, the background ARV medications will be optimized and subjects will remain on blinded TPV/RTV plus optimized background therapy for the duration of the trial. Trial duration ranges between 12-32 weeks, depending on when the subject is entered into the trial and the interim analyses for determination of optimized TPV/RTV regimen is completed. On determination of the optimal TPV/RTV dose, subjects may opt to continue open-label treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Female subjects who:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Orange County Center for Special Immunology | |
| Fountain Valley, California, United States, 92708 | |
| Living Hope Clinical Trials Inc. | |
| Long Beach, California, United States, 90813 | |
| University of California, Los Angeles Medical Center | |
| Los Angeles, California, United States, 90095 | |
| AHF Research Center | |
| Los Angeles, California, United States, 90027 | |
| ID Care, Inc. | |
| Los Angeles, California, United States, 90046 | |
| Tower I.D. Medical Assoc., Inc. | |
| Los Angeles, California, United States, 90048 | |
| University of So. California / LA County USC Medical Center | |
| Los Angeles, California, United States, 90033 | |
| Pacific Horizon Medial Group | |
| San Francisco, California, United States, 94115 | |
| University of California San Francisco Positive Health Program Research | |
| San Francisco, California, United States, 94110 | |
| United States, District of Columbia | |
| Dupont Circle Physicians Group | |
| Washington, District of Columbia, United States, 20009 | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| (IDC) Research Institute | |
| Altamonte Springs, Florida, United States, 32701 | |
| Therafirst Medical Center | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Jackson Medical Tower | |
| Miami, Florida, United States, 33136 | |
| Steinhart Medical Associates | |
| South Miami, Florida, United States, 33133 | |
| Hillsborough County Health Dept. | |
| Tampa, Florida, United States, 33602 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Atlanta VA Medical Center, Dept. of ID | |
| Decatur, Georgia, United States, 30033 | |
| Mercer University School of Medicine | |
| Macon, Georgia, United States, 31207 | |
| United States, Illinois | |
| CORE Center, Cook County Hospital | |
| Chicago, Illinois, United States, 60612 | |
| Rush Presbyterian/St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| HIV Outpatient Program (H.O.P.) | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| John's Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | |
| Boston, Massachusetts, United States, 02125 | |
| CRI Community Research Initiative | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Michigan | |
| University of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
| Henry Ford Hospital, Infectious Diseases Dept. | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| Kansas City Free Health Clinic | |
| Kansas City, Missouri, United States, 64111 | |
| Washington University AIDS Clinical Trial Unit | |
| St. Louis, Missouri, United States, 63108 | |
| United States, Nevada | |
| Wellness Center | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| ID Care, Inc. | |
| Hillsborough, New Jersey, United States, 08844 | |
| ID Care, Inc. | |
| Randolph, New Jersey, United States, 07869 | |
| United States, New Mexico | |
| Southwest CARE Center | |
| Santa Fe, New Mexico, United States, 97505 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| University of New York at Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University Medical Center Infectious Diseases Clinic | |
| Durham, North Carolina, United States, 27710 | |
| Jemsek Clinic | |
| Huntersville, North Carolina, United States, 28078 | |
| Wake Forest University Baptist Medical Center | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Infect. Disease Institute, Clinical Trials Unit | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, South Carolina | |
| Burnside Clinic | |
| Columbia, South Carolina, United States, 29206 | |
| United States, Tennessee | |
| Vanderbilt University - AIDS Clinical Trial Unit | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Nelson-Tebedo Clinic | |
| Dallas, Texas, United States, 75219 | |
| Gathe Clinic | |
| Houston, Texas, United States, 77004 | |
| United States, Virginia | |
| Infectious Disease Physicians Research | |
| Annandale, Virginia, United States, 22003 | |
| Puerto Rico | |
| Clinical Research Puerto Rico | |
| San Juan, Puerto Rico, 00923 | |
More Information
| Study ID Numbers: | BI 1182.52 |
| Study First Received: | May 2, 2002 |
| Last Updated: | September 19, 2005 |
| ClinicalTrials.gov Identifier: | NCT00034866 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV treatment experienced Boehringer tipranavir ritonavir |
|
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 |