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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00034866
First received: May 2, 2002
Last updated: September 19, 2005
Last verified: September 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Estimated Enrollment: 165
Study Start Date: April 2002
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  1. ARV medication naïve.
  2. 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).
  3. Any active opportunistic infection within 60 days before study entry.
  4. Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT >Grade 1.
  5. Prior tipranavir use.
  6. 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.
  7. Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
  8. Use of immunomodulatory drugs (e.g. interferon, cyclosporin, hydroxyurea, interleukin-2).
  9. Active substance abuse.
  10. Inability to swallow TPV or RTV capsules.
  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

  Hide Study Locations
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
ID Care, Inc.
Los Angeles, California, United States, 90046
AHF Research Center
Los Angeles, California, United States, 90027
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

Keywords provided by Boehringer Ingelheim:
HIV
treatment experienced
Boehringer
tipranavir
ritonavir

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
Ritonavir
HIV Protease Inhibitors
Tipranavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014