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RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir Clinical research trials and RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir. RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir clinical trial. Test subjects typically receive the most expert healthcare available for their RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir  RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir
RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: RESIST 1 will be conducted in HIV-positive adults that have been treated with multiple antiretroviral (ARV) drugs. It is a randomized, open-label study that will compare the safety and effectiveness of tipranavir given with low-dose ritonavir to that of another protease inhibitor (selected by the doctor) given with low-dose ritonavir. Patients will remain in the study for 48 weeks, with an up to 48 week extension phase.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Screening HIV-genotype indicating at least one primary PI mutation among 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and, no more than two of the following codons carrying mutations: 33, 82, 84 or 90. - Greater than or equal to 3 months experience taking ARVs from each of the classes (NRTI, NNRTI and PI) with at least two PI-based regimens, one which must be current for greater than or equal to 3 months prior to study. - HIV VL greater than or equal to 1,000 copies/ml - Screening lab values indicating adequate baseline organ function, i.e. total cholesterol less than or equal to 400mg/dl, total triglycerides less than or equal to 750mg/dl, ALT less than or equal to 3.0xULN, AST less than or equal to 2.5xULN, any grade GGT, and grade CK w/o myopathy, and all other lab values less than or equal to DAIDS Grade 1. - Acceptable medical history with chest X-ray and ECG within 1 year of study. - Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with cytochrome P450 system. - A prior AIDS defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months. ARC is acceptable. - Any CD4 count is acceptable. EXCLUSION CRITERIA: - ARV medication naïve. - Patients on recent drug holiday (off ARV meds for at least 7 consecutive days within the last 90 days) - Screening HIV genotype report showing resistance to all comparator PIs (amprenavir, indinavir, lopinavir and saquinavir) - ALT>3.0xULN, AST>2.5xULN (>DAIDS Grade 1) at either screening visit. - Female patients of child-bearing potential who: have a positive serum pregnancy test at screening or during the study, are breast feeding, are planning to become pregnant, are not willing to use barrier method contraception, or require ethinyl estradiol (oral, patch, injection) for contraception—use for hormone replacement therapy is acceptable. - Prior tipranavir use. - Use of investigational meds within 30 days before study entry or during study (T-20 will be allowed before and during study)(Atazanavir will NOT be allowed during study, but prior use is acceptable, including as the current PI regimen—see incl. criterion 2) - Use of immunomodulatory drugs within 30 days before study (IFN, IL-2, hydroxyurea, cyclosporin) - Inability to adhere to protocol, including active substance abuse as assessed by the investigator. - In the opinion of the investigator, likely survival of <12 months due to underlying disease.
Total Enrollment:
Location and Contact Information:
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
San Antonio Infectious Diseases Consultants
San Antonio, Texas, 78229
United States
Early Intervention Program (EIP) Clinic
Camden, New Jersey, 08103
United States
Beth Israel Medical Center
New York City, New York, 10003
United States
Circle Medical, LLC
Norwalk, Connecticut, 06851
United States
National Naval Medical Center
Bethesda, Maryland, 20889
United States
UCLA Medical Center
Los Angeles, California, 90095
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
AHF Research Center
Los Angeles, California, 90027
United States
Dallas Veteran's Affairs Medical Center
Dallas, Texas, 75216
United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009
United States
Indiana University Hospital
Indianapolis, Indiana, 46202
United States
John's Hopkins University School of Medicine
Baltimore, Maryland, 21205
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Orange County Center for Special Immunology
Fountain Valley, California, 92708
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Washington Harborview Medical Center
Seattle, Washington, 98104
United States
Living Hope Clinical Trials Inc.
Long Beach, California, 90813
United States
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157
United States
Jemsek Clinic
Huntersville, North Carolina, 28078
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Brigham's Women's Hospital
Boston, Massachusetts, 02115
United States
Community Reasearch Initiative of New England
Boston, Massachusetts, 02125
United States
Washington University AIDS Clinical Trial Unit
St. Louis, Missouri, 63108
United States
University of California Davis Medical Center, ACTU at CARES
Sacramento, California, 95814
United States
The office of Dr. Bellman
New York City, New York, 10003
United States
CORE Center, Cook County Hospital
Chicago, Illinois, 60612
United States
Massachussetts General Hospital
Boston, Massachusetts, 02114
United States
University of Tennessee at Memphis
Memphis, Tennessee, 38103
United States
Mercer University School of Medicine
Macon, Georgia, 31207
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Joseph Gathe, MD
Houston, Texas, 77004
United States
Veteran's Affairs New Jersey Health Care System
East Orange, New Jersey, 07018
United States
Jackson Medical Tower
Miami, Florida, 33136
United States
Community Health Network
Rochester, New York, 14604
United States
Infectious Disease Physicians Research
Annandale, Virginia, 22003
United States
San Francisco Veteran's Affairs Medical Center
San Francisco, California, 94121
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
United States
Albany Medical College
Albany, New York, 12208
United States
Atlanta VA Medical Center
Decatur, Georgia, 30033
United States
Pollari Medical Group
New York City, New York, 10011
United States
The Miriam Hospital
Providence, Rhode Island, 02906
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
AIDS Community Research Initiative of America
New York City, New York, 10018
United States
Bruce Rashbaum, MD
Washington D.C., District of Columbia, 20037
United States
CARES Resource
Coral Gables, Florida, 33146
United States
El Rio SIA
Tucson, Arizona, 85745
United States
Kaiser Permanente Medical Center
San Francisco, California, 94118
United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
Pacific Horizon Medical Group
San Francisco, California, 94115
United States
Infectious Disease Research Institute
Tampa, Florida, 33614
United States
Mount Vernon Hospital
Mount Vernon, New York, 10550
United States
Infectious Diseases Clinics of Emory
Atlanta, Georgia, 30308
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Fenway Community Health
Boston, Massachusetts, 02115
United States
Rush Presbyterian - St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Northstar Medical
Chicago, Illinois, 60657
United States
LA County USC Medical Center
Los Angeles, California, 90033
United States
Wellness Center
Las Vegas, Nevada, 89102
United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19014
United States
AIDS Consortium Service, MMC
Portland, Maine, 04192
United States
VCU Health Systems, Infectious Disease Clinic
Richmond, Virginia, 23298
United States
Boulevard Comprehensive Care Center
Jacksonville, Florida, 32206
United States
Community Health Center
Harrisburg, Pennsylvania, 17110
United States
State University of New York at Stony Brook
Stony Brook, New York, 11794
United States
Kansas City Free Health Clinic
Kansas City, Missouri, 64111
United States
Washington VAMC
Washington D.C., District of Columbia, 20422
United States
Community Research Initiative of New England
Springfield, Massachusetts, 01107
United States
University of Connecticut Health Center
Farmington, Connecticut, 06030
United States
UCSD Antiviral Research Center
San Diego, California, 92103
United States
Wohlfeiler, Piperato & King, MD
Miami, Florida, 33139
United States
Southwest CARE Center
Santa Fe, New Mexico, 87505
United States
Noth Texas Center for AIDS and Clinical Research
Dallas, Texas, 75208-4234
United States
North Broward Hospital District, HIV Clinical Research
Ft. Lauderdale, Florida, 33311
United States
Comprehensive Research
Tampa, Florida, 33607
United States
Greenville Hospital System
Greenville, South Carolina, 29605
United States
Associates in Research
Ft. Myers, Florida, 33901
United States
Froedert Memorial Luthern Hospital
Milwaukee, Wisconsin, 52336
United States
Health Innovations Research
Los Angeles, California, 90046
United States
(IDC) Research Initiative
Altamonte Springs, Florida, 32701
United States
Infectious Disease Associates
Sarasota, Florida, 34239
United States
HIV Outpatient Program (H.O.P)
New Orleans, Louisiana, 70112
United States
Clinical Research Puerto Rico, Inc.
Santurce, , 00909
Puerto Rico
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Burnside Clinic
Columbia, South Carolina, 29206
United States
Denver Infectious Disease Consultants
Denver, Colorado, 80220
United States
North Texas Center for AIDs and Clinical Research
Dallas, Texas, 75208
United States
OK University Medical Center, Infectious Disease Institute
Oklahoma City, Oklahoma, 73103
United States
Family Practice Medical Center, Ryan White Clinic
Boise, Idaho, 83704
United States
Infectious Disease of Indiana, P.S.C.
Indianapolis, Indiana, 46202
United States
East Bay AIDS Center
Berkeley, California, 94705
United States
Hillsborough County Health Dept.
Tampa, Florida, 33602
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
The Cornell Clinical Trials Unit
New York City, New York, 10011
United States
Summa Health System, HIV CARE Center
Akron, Ohio, 44308
United States
Naval Medical Center
San Diego, California, 92132
United States
Additional Information:
Study ID Numbers: BI 1182.12;
Study Start Date: February 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054717
Other Hiv Infections Studies:
1. A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
2. The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients
3. A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
4. An Electronic Pillbox for People With HIV
5. The Effect of Valacyclovir on the Detection of HIV from Genital Herpes Lesions in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Kentucky Clinical Trials
Other Louisville Clinical Trials
RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir
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