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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Tipranavir/ritonavir	Phase III

Further Study Details: 

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85006,  United States
      El Rio SIA, Tucson,  Arizona,  85745,  United States
California
      East Bay AIDS Center, Berkeley,  California,  94705,  United States
      Orange County Center for Special Immunology, Fountain Valley,  California,  92708,  United States
      Living Hope Clinical Trials Inc., Long Beach,  California,  90813,  United States
      AHF Research Center, Los Angeles,  California,  90027,  United States
      Health Innovations Research, Los Angeles,  California,  90046,  United States
      Pacific Horizon Medical Group, San Francisco,  California,  94115,  United States
      Kaiser Permanente Medical Center, San Francisco,  California,  94118,  United States
      San Francisco Veteran's Affairs Medical Center, San Francisco,  California,  94121,  United States
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      UCLA Medical Center, Los Angeles,  California,  90095,  United States
      LA County USC Medical Center, Los Angeles,  California,  90033,  United States
      UCSD Antiviral Research Center, San Diego,  California,  92103,  United States
      University of California Davis Medical Center, ACTU at CARES, Sacramento,  California,  95814,  United States
      Naval Medical Center, San Diego,  California,  92132,  United States
Colorado
      Denver Infectious Disease Consultants, Denver,  Colorado,  80220,  United States
Connecticut
      Circle Medical, LLC, Norwalk,  Connecticut,  06851,  United States
      University of Connecticut Health Center, Farmington,  Connecticut,  06030,  United States
District of Columbia
      Bruce Rashbaum, MD, Washington,  District of Columbia,  20037,  United States
      Washington VAMC, Washington,  District of Columbia,  20422,  United States
      Dupont Circle Physician's Group, Washington,  District of Columbia,  20009,  United States
Florida
      (IDC) Research Initiative, Altamonte Springs,  Florida,  32701,  United States
      CARES Resource, Coral Gables,  Florida,  33146,  United States
      Associates in Research, Fort Myers,  Florida,  33901,  United States
      Boulevard Comprehensive Care Center, Jacksonville,  Florida,  32206,  United States
      Steinhart Medical Associates, Miami,  Florida,  33133,  United States
      Wohlfeiler, Piperato & King, MD, Miami Beach,  Florida,  33139,  United States
      Infectious Disease Associates, Sarasota,  Florida,  34239,  United States
      Comprehensive Research, Tampa,  Florida,  33607,  United States
      Hillsborough County Health Dept., Tampa,  Florida,  33602,  United States
      Infectious Disease Research Institute, Tampa,  Florida,  33614,  United States
      Treasure Coast Infectious Disease Consultants, Vero Beach,  Florida,  32960,  United States
      North Broward Hospital District, HIV Clinical Research, Ft. Lauderdale,  Florida,  33311,  United States
      Jackson Medical Tower, Miami,  Florida,  33136,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
      Atlanta VA Medical Center, Decatur,  Georgia,  30033,  United States
      Mercer University School of Medicine, Macon,  Georgia,  31207,  United States
      Infectious Diseases Clinics of Emory, Atlanta,  Georgia,  30308,  United States
Idaho
      Family Practice Medical Center, Ryan White Clinic, Boise,  Idaho,  83704,  United States
Illinois
      CORE Center, Cook County Hospital, Chicago,  Illinois,  60612,  United States
      Rush Presbyterian - St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      Northstar Medical, Chicago,  Illinois,  60657,  United States
Indiana
      Infectious Disease of Indiana, P.S.C., Indianapolis,  Indiana,  46202,  United States
      Indiana University Hospital, Indianapolis,  Indiana,  46202,  United States
Kentucky
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536,  United States
      University of Louisville, Louisville,  Kentucky,  40202,  United States
Louisiana
      HIV Outpatient Program (H.O.P), New Orleans,  Louisiana,  70112,  United States
Maine
      AIDS Consortium Service, MMC, Portland,  Maine,  04192,  United States
Maryland
      John's Hopkins University School of Medicine, Baltimore,  Maryland,  21205,  United States
      National Naval Medical Center, Bethesda,  Maryland,  20889,  United States
Massachusetts
      Community Reasearch Initiative of New England, Boston,  Massachusetts,  02125,  United States
      Fenway Community Health, Boston,  Massachusetts,  02115,  United States
      Community Research Initiative of New England, Springfield,  Massachusetts,  01107,  United States
      Massachussetts General Hospital, Boston,  Massachusetts,  02114,  United States
      Brigham's Women's Hospital, Boston,  Massachusetts,  02115,  United States
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      University of Michigan Health System, Ann Arbor,  Michigan,  48109,  United States
Missouri
      Kansas City Free Health Clinic, Kansas City,  Missouri,  64111,  United States
      Washington University AIDS Clinical Trial Unit, St. Louis,  Missouri,  63108,  United States
Nevada
      Wellness Center, Las Vegas,  Nevada,  89102,  United States
New Jersey
      Veteran's Affairs New Jersey Health Care System, East Orange,  New Jersey,  07018,  United States
      Early Intervention Program (EIP) Clinic, Camden,  New Jersey,  08103,  United States
New Mexico
      Southwest CARE Center, Santa Fe,  New Mexico,  87505,  United States
New York
      Albany Medical College, Albany,  New York,  12208,  United States
      Mount Vernon Hospital, Mount Vernon,  New York,  10550,  United States
      AIDS Community Research Initiative of America, New York,  New York,  10018,  United States
      Pollari Medical Group, New York,  New York,  10011,  United States
      Beth Israel Medical Center, New York,  New York,  10003,  United States
      State University of New York at Stony Brook, Stony Brook,  New York,  11794,  United States
      Community Health Network, Rochester,  New York,  14604,  United States
      Westchester Medical Center, Valhalla,  New York,  10595,  United States
      The Cornell Clinical Trials Unit, New York,  New York,  10011,  United States
      The office of Dr. Bellman, New York,  New York,  10003,  United States
North Carolina
      Jemsek Clinic, Huntersville,  North Carolina,  28078,  United States
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States
      Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157,  United States
Ohio
      Ohio State University Medical Center, Columbus,  Ohio,  43210,  United States
      University of Cincinnati Medical Center, Cincinnati,  Ohio,  45267,  United States
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States
      Summa Health System, HIV CARE Center, Akron,  Ohio,  44308,  United States
Oklahoma
      OK University Medical Center, Infectious Disease Institute, Oklahoma City,  Oklahoma,  73103,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States
      University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19014,  United States
      Community Health Center, Harrisburg,  Pennsylvania,  17110,  United States
Rhode Island
      The Miriam Hospital, Providence,  Rhode Island,  02906,  United States
South Carolina
      Burnside Clinic, Columbia,  South Carolina,  29206,  United States
      Greenville Hospital System, Greenville,  South Carolina,  29605,  United States
Tennessee
      University of Tennessee at Memphis, Memphis,  Tennessee,  38103,  United States
Texas
      Joseph Gathe, MD, Houston,  Texas,  77004,  United States
      San Antonio Infectious Diseases Consultants, San Antonio,  Texas,  78229,  United States
      Dallas Veteran's Affairs Medical Center, Dallas,  Texas,  75216,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      University of Texas Medical Branch at Galveston, Galveston,  Texas,  77555,  United States
      North Texas Center for AIDs and Clinical Research, Dallas,  Texas,  75208,  United States
      Noth Texas Center for AIDS and Clinical Research, Dallas,  Texas,  75208-4234,  United States
Virginia
      Infectious Disease Physicians Research, Annandale,  Virginia,  22003,  United States
      VCU Health Systems, Infectious Disease Clinic, Richmond,  Virginia,  23298,  United States
Washington
      Northwest Medical Specialties, Tacoma,  Washington,  98405,  United States
      University of Washington Harborview Medical Center, Seattle,  Washington,  98104,  United States
Wisconsin
      Froedert Memorial Luthern Hospital, Milwaukee,  Wisconsin,  52336,  United States
Puerto Rico
      Clinical Research Puerto Rico, Inc., Santurce,  00909,  Puerto Rico

Study ID Numbers:  BI 1182.12
Record last reviewed:  March 2005
Last Updated:  March 22, 2005
Record first received:  February 7, 2003
ClinicalTrials.gov Identifier:  NCT00054717
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08