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Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI
This study has been terminated.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00517192
  Purpose

The objective of this study is to compare the efficacy and safety of TPV/r (500mg/200mg BID) to the safety and efficacy of DRV/r (600 mg /100 mg BID) in combination with investigator selected optimised background regimens in patients who are 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 virtual phenotype resistance testing.


Condition Intervention Phase
HIV Infections
Drug: Tipranavir
Drug: Darunavir
Drug: Ritonavir
Phase IV

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir Darunavir Darunavir ethanolate Tipranavir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Open-Labelled, Multi-Centre Trial Comparing the Safety and Efficacy of Ritonavir-Boosted Aptivus (Tipranavir, TPV/r) to That of Prezista? (Darunavir, DRV/r) in Three-Class (NRTI, NNRTI, and PI) Treatment-Experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint of this study is time to virologic failure using VL < 50 copies/mL to determine virologic response (and VL < 500 to determine virologic rebound). [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • The key secondary endpoint for this study will be treatment response at week 48, using VL < 50 as the response criterion with the NonCompleters equals Failures (NCF) approach for handling patients that discontinue study drug early. [ Time Frame: every clinic visit, 24 weeks and 48 weeks ]

Estimated Enrollment: 800
Study Start Date: September 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tipranavir
    500mg TPV BID
    Drug: Darunavir
    600mg DRV BID
    Drug: Ritonavir
    200mg or 100mg RTV BID
  Eligibility

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

Inclusion Criteria:

  1. Three-class (NRTI, NNRTI, and PI) treatment-experienced patients (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.
  2. Patients optimized background regimen must contain at least two active ARVs including Efuvirtide, Maraviroc and integrase inhibitors.
  3. Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization.
  4. An HIV-1 viral load of at least 1,000 copies/mL at screening.
  5. A CD4+ cell count of at least 50 cells/mm3 at screening.

9. Acceptable screening laboratory values that indicate adequate baseline organ function.

Exclusion Criteria:

  1. Previous use of TPV or DRV.
  2. Full genotypic resistance (reported as minimal response) to TPV or DRV on screening virtual phenotype:
  3. Female patient of child-bearing potential who:

    has a positive serum pregnancy test at screening or during the study, is breast feeding, is planning to become pregnant, is not willing to use barrier methods of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.

  4. History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
  5. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
  6. Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
  7. Current use of systemic cytotoxic chemotherapy.
  8. All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517192

  Show 78 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: 1182.71
Study First Received: August 15, 2007
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00517192  
Health Authority: United States: Food and Drug Administration Argentina: Italy: Comitato Etico Azienda Spedali Civili di Brescia France: AFSSAPS Poland: Romania: Austria: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Wars

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

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009