Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Safety and Antiviral Activity of TPV in HCV and/or HBV HIV co-Infected Patients TDM Randomized Pilto Evaluation
This study has been terminated.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00447902
  Purpose

The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or HBV co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.


Condition Intervention Phase
HIV Infections
Drug: tipranavir
Drug: ritonavir
Phase III

MedlinePlus related topics: AIDS Hepatitis
Drug Information available for: Hepatitis B Vaccines Ritonavir Tipranavir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Antiviral Activity of TPV in Hepatitis C or Hepatitis B HIV co-Infected Patients - TDM Randomized Pilot Evaluation

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The efficacy endpoint is a confirmed virologic response at Week 48 (viral load <50 copies/mL at two consecutive measurements at least 5 days apart). The safety endpoint is the occurrence of dose limiting hepatotoxicity during the study. [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • Other endpoints: occurrence of severe hepatotoxicity; >1 log 10 drop in viral load from baseline, viral load <50 & 400 copies/ml at each visit, time to treatment failure and AIDS or death, patients adherence, PK impacting TPV/r dosing with safety. [ Time Frame: 24 and 48 weeks or as otherwise indicated in the protocol ]

Enrollment: 11
Study Start Date: March 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 infected males or females at least 18 years of age.
  2. Three-class (NRTI, NNRTI, and PI) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI (on the screening resistance testing).
  3. CD4+ T lymphocyte count more than 50 cells/micro l and HIV 1 VL more than 1000 copies/mL at screening.
  4. Patients must have at least one of the following permutations of active ARV medications available and must be willing to use them in the OBR for trial inclusion.
  5. Chronic hepatitis C Virus infection demonstrated by HCV-RNA positivity or, Chronic hepatitis B infection demonstrated by anti HBc IgG Antibody and HB Surface Antigen positivity.
  6. Acceptable screening laboratory values that indicate adequate baseline organ function.
  7. ALT and AST <DAIDS Grade 3.
  8. Acceptable medical history, as assessed by the investigator.
  9. Only the four AIDS defining events listed below are acceptable as long as the event has been cured for at least 2 weeks before screening (Visit 1). Patients with history of other AIDS defining events are not allowed into the trial. The acceptable prior AIDS defining events include: Candidiasis (bronchi, trachea, lungs, esophageal), Herpes simplex: chronic ulcer(s) (more than 1 months duration), bronchitis, pneumonitis, or esophagitis, Mycobacterium tuberculosis (pulmonary or extrapulmonary), Pneumonia including Pneumocystis jiroveci (formerly carinii) pneumonia.
  10. A reliable method of barrier contraception will be used by all female patients who are of reproductive potential, for at least three months prior to Visit 3, during the trial, and 30 days after completion or termination from the trial.

Exclusion Criteria:

  1. Prior tipranavir use.
  2. Known hypersensitivity to any of the ingredients to the tipranavir or ritonavir formulations.
  3. ARV medication naive.
  4. Genotypic resistance to TPV (defined as a TPV mutation score of more than 7).
  5. Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the month prior to screening.
  6. Decompensated liver disease, including presence or history of ascites, variceal bleeding, or hepatic encephalopathy or having ever been diagnosed as having hepatic insufficiency of Child Pugh class B or C.
  7. Female patients of childbearing 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 a barrier method of contraception, or
    • are only willing to use an estrogen-containing medication, e.g., ethinyl estradiol, as a method of contraception.
    • Use of investigational medications within 30 days before study entry or during the trial except for those investigationnal ARV drugs permitted during the trial as stated in inclusion criteria 6.
    • Use of concomitant drugs that may significantly reduce plasma levels of the study medications.
    • Use of immunomodulatory drugs or antineoplastic agents within 30 days before study entry or during the trial.
    • Inability to adhere to the requirements of the protocol, including active substance abuse, as defined by the investigator.
    • Anticipated need for an interferon-based regimen in the 48 weeks following the study entry.
    • Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis.
    • Any active infection or neoplasm currently being treated.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447902

  Show 68 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1182.99, EudraCT No.: 2005-005023-33
Study First Received: March 14, 2007
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00447902  
Health Authority: United States: Food and Drug Administration;   Brazil: Agência Nacional de Vigilância Sanitária - ANVISA;   France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS);   Italy: Comitato Etico Locale per la Sperimentazione Clinica Osp. L. Sacco - Milano;   Portugal: INFARMED - Instituto Nacional da Farmácia e do Medicamento;   Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos Y Tecnología)

Keywords provided by Boehringer Ingelheim Pharmaceuticals:
treatment experienced

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Hepatitis B
Hepatitis C
Retroviridae Infections
Immunologic Deficiency Syndromes
Tipranavir

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Anti-Retroviral Agents
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009