Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
NCT ID: NCT00447902
Last Updated: 2014-05-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
11 participants
INTERVENTIONAL
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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tipranavir
ritonavir
Eligibility Criteria
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Inclusion Criteria
2. Three-class (Nucleoside reverse transcriptase inhibitor (NRTI), Non nucleoside reverse transcriptase inhibitor (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI (on the screening resistance testing). Patients that are NNRTI-naïve patients but who have genotypically documented NNRTI-resistance mutations on past or screening resistance testing would be eligible.
3. CD4+ T lymphocyte count ≥50 cells/µl and HIV-1 VL ≥1000 copies/mL at screening.
4. The ARV study treatment regimen must consist of new TPV/r in combination with an OBR of 2-4 agents of the following: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, an Expanded Access Program (EAP) investigational agent (Section 3.3). In total, patients are to have an ARV study treatment regimen consisting of at least 3 agents (TPV/r and two OBRs).
5. Chronic hepatitis C Virus (HCV) infection demonstrated by HCV-ribonucleic acid (RNA) positivity or, Chronic hepatitis B (HB) infection demonstrated by anti HBc IgG Antibody and HB Surface Antigen positivity.
6. Acceptable screening laboratory values that indicate adequate baseline organ function.
7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< Division of AIDS (DAIDS) Grade 3.
8. Acceptable medical history, as assessed by the investigator.
9. Any AIDS defining illness listed in the Appendix 10.3.1 should be accepted as long as is resolved, asymptomatic or stable on treatment for at least 12 weeks before screening (Visit 1); the AIDS defining events listed below are not acceptable History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
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.
11. Karnofsky performance score ≥70.
9. Use of concomitant drugs that may significantly reduce plasma levels of the study medications.
10. Use of immunomodulatory drugs or antineoplastic agents within 30 days before study entry or during the trial.
11. Inability to adhere to the requirements of the protocol, including active substance abuse, as defined by the investigator.
12. Anticipated need for an interferon-based regimen in the 48 weeks following the study entry.
13. Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis.
14. Any active infection or neoplasm currently being treated.
15. Patients with history of hemorrhagic stroke or intracranial aneurysm.
16. Patients with history of ischemic stroke, neurosurgery, skull trauma and/or intracranial pathology (arteriovenous malformation, brain tumors and cerebral venous thrombosis) within 4 weeks prior to screening (Visit 1) as assessed by investigator.
17. Patients with current history of alcohol abuse defined as alcohol consumption that would interfere with patient's compliance or result in biological abnormalities.
Exclusion Criteria
2. Known hypersensitivity to any of the ingredients to the tipranavir or ritonavir formulations.
3. ARV medication naive.
4. Genotypic resistance to Tipranavir (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,
* 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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1182.99.32 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1182.99.31 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1182.99.12 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
1182.99.1 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1182.99.4 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1182.99.54001
Capital Federal, , Argentina
1182.99.55002 Hospital DIA
Sacomã - São Paulo, , Brazil
1182.99.55004 Unidade de Referência em doenças Infecciosas Preveníveis
Santo André, , Brazil
1182.99.55001 Universidade Federal de Sao Paulo
São Paulo, , Brazil
1182.99.55003 Centro de Referência e Treinamento - DST/AIDS
Vila Mariana - Sao Paulo, , Brazil
1182.99.3301A Boehringer Ingelheim Investigational Site
Garches, , France
1182.99.3306G Boehringer Ingelheim Investigational Site
Nantes, , France
1182.99.3306K Boehringer Ingelheim Investigational Site
Nantes, , France
1182.99.3310C Boehringer Ingelheim Investigational Site
Nice, , France
1182.99.3310D Boehringer Ingelheim Investigational Site
Nice, , France
1182.99.3310E Boehringer Ingelheim Investigational Site
Nice, , France
1182.99.3310F Boehringer Ingelheim Investigational Site
Nice, , France
1182.99.3310G Boehringer Ingelheim Investigational Site
Nice, , France
1182.99.3310H Boehringer Ingelheim Investigational Site
Nice, , France
1182.99.3304A Boehringer Ingelheim Investigational Site
Paris, , France
1182.99.3304C Boehringer Ingelheim Investigational Site
Paris, , France
1182.99.3302A Boehringer Ingelheim Investigational Site
Perpignan, , France
1182.99.4909 Boehringer Ingelheim Investigational Site
Düsseldorf, , Germany
1182.99.3912 Boehringer Ingelheim Investigational Site
Ancona, , Italy
1182.99.3901 Boehringer Ingelheim Investigational Site
Milan, , Italy
1182.99.3911 Boehringer Ingelheim Investigational Site
Milan, , Italy
1182.99.3916 Boehringer Ingelheim Investigational Site
Milan, , Italy
1182.99.3906 Boehringer Ingelheim Investigational Site
Pavia, , Italy
1182.99.3402
Barcelona, , Spain
1182.99.3407
Madrid, , Spain
Countries
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Other Identifiers
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EudraCT No.: 2005-005023-33
Identifier Type: -
Identifier Source: secondary_id
1182.99
Identifier Type: -
Identifier Source: org_study_id
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