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Clinical Trials

MainTitle

Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals

This study has been completed
Sponsor
Boehringer Ingelheim


Information provided by (Responsible Party)
Boehringer Ingelheim
ClinicalTrials.gov Identifier
NCT00034866

First received: May 2, 2002
Last updated: September 19, 2005
Last Verified: September 2005
History of Changes
Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.

Further study details as provided by Boehringer Ingelheim:

Enrollment: 165
Study Start Date: April 2002
Study Completion Date: October 2002

Detailed Description:

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  1. Signed informed consent prior to trial participation.
  2. HIV-1 infected males or females >= 18 years of age.
  3. At least 3 months experience taking NRTIs, NNRTI(s), and PIs.
  4. Current PI-based ARV medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
  5. HIV-1 viral load >= 1000 copies/mL at screening.
  6. Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M, with not more than one of 82 A/F/T or 84V or 90M.
  7. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if severity is no higher than Grade 3 GGT, Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the DAIDS Grading Scale. All laboratory values outside these limits are subject to approval by BI.
  8. Acceptable medical history, as assessed by the investigator, with chest X-ray and ECG within 1 year of study participation.
  9. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system, such as: grapefruit or Seville oranges or their products; herbal preparations containing St. John’s Wort or milk thistle, and garlic supplements.
  10. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment for at least 2 months.

  • Exclusion Criteria:
  • ARV medication naïve.
  • Female subjects 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 two barrier methods of contraception (e.g. latex condom plus spermicidal jelly/foam).
  • Any active opportunistic infection within 60 days before study entry.
  • Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT >Grade 1.
  • Prior tipranavir use.
  • Use of investigational medications within 30 days before study entry or during the trial. Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
  • Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
  • Use of immunomodulatory drugs (e.g. interferon, cyclosporin, hydroxyurea, interleukin-2).
  • Active substance abuse.
  • Inability to swallow TPV or RTV capsules.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00034866

    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
    AHF Research Center
    Los Angeles, California, United States, 90027
    University of So. California / LA County USC Medical Center
    Los Angeles, California, United States, 90033
    ID Care, Inc.
    Los Angeles, California, United States, 90046
    Tower I.D. Medical Assoc., Inc.
    Los Angeles, California, United States, 90048
    University of California, Los Angeles Medical Center
    Los Angeles, California, United States, 90095
    University of California San Francisco Positive Health Program Research
    San Francisco, California, United States, 94110
    Pacific Horizon Medial Group
    San Francisco, California, United States, 94115
    United States, District of Columbia
    Georgetown University Medical Center
    Washington, District of Columbia, United States, 20007
    Dupont Circle Physicians Group
    Washington, District of Columbia, United States, 20009
    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
    Albany Medical College
    Albany, New York, United States, 12208
    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
    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

    Sponsors and Collaborators

    Boehringer Ingelheim
    More Information

    More Information


    Responsible Party: Boehringer Ingelheim  
    ClinicalTrials.gov Identifier: NCT00034866   History of Changes  
    Other Study ID Numbers: BI 1182.52  
    Study First Received: May 2, 2002  
    Last Updated: September 19, 2005  

    Keywords provided by Boehringer Ingelheim:

    HIV
    treatment experienced
    Boehringer
    tipranavir
    ritonavir

    Additional relevant MeSH terms:
    HIV Infections
    Ritonavir
    HIV Protease Inhibitors
    Tipranavir
    Protease Inhibitors

    ClinicalTrials.gov processed this data on October 23, 2017
    This information is provided by ClinicalTrials.gov.