Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00144170
  Purpose

The objective of this study is to demonstrate the safety and efficacy of TPV/RTV versus an active control arm in highly treatment experienced HIV-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring PI-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.


Condition Intervention Phase
HIV Infections
Drug: Tipranavir (with low dose ritonavir)
Phase III

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir Tipranavir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Open-Label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-Defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-Experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoints of the study are the proportion of patients with a treatment response at 48 weeks and the time to treatment failure through 48 weeks. [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • The key secondary endpoint of the study to be assessed at an interim analysis, is the proportion of patients with a virologic response at 16 weeks. Additional secondary endpoints are listed in the protocol. [ Time Frame: 16, 24, 48 and 96 weeks ]

Enrollment: 882
Study Start Date: February 2003
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. Signed informed consent prior to trial participation.
  2. HIV-1 infected males or females >=18 years of age.
  3. Screening genotypic resistance report indicating both of the following:

    • at least one primary PI mutation at the following sites 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M , and
    • no more than two protease mutations on codons 33, 82, 84, or 90 .
  4. At least 3 consecutive months experience taking ARVs from each of the classes of NRTI(s), NNRTI(s) , and PIs at some point in treatment history,

    • with at least 2 PI-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and
    • current PI-based ARV medication regimen for at least 3 months prior to randomisation.
  5. HIV-1 viral load >=1000 copies/mL at screening .
  6. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:

    • Total Cholesterol <=400 mg/dl or 10,36 mm/L (<=CTC Grade 2).
    • Total Triglycerides <=750 mg/dl or 8,5 mm/L (<=DAIDS Grade 2).
    • ALT <=3x ULN and AST<=2.5x ULN (<=DAIDS Grade 1) .
    • Any Grade GGT is acceptable.
    • Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
    • All other laboratory test values <=DAIDS Grade 1.
  7. Acceptable medical history, as assessed by the investigator, with chest X-ray and ECG within 1 year of study participation.
  8. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Section 4.2.2 and Appendix 11.7 of protocol).
  9. A prior AIDS defining event (as listed in Appendix 11.1) is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months. (AIDS related complex is acceptable.)

Exclusion Criteria:

  1. ARV medication naïve.
  2. Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months.
  3. ALT >3x ULN and AST >2.5x ULN (>DAIDS Grade 1, refer Appendix 11.3) at either screening visit.
  4. Female patients of child-bearing potential who:

    • have a positive serum pregnancy test at screening or during the study,
    • are breast feeding
    • are planning to become pregnant, or
    • are not willing to use a barrier method of contraception, or
    • require ethinyl estradiol administration
  5. Prior tipranavir use.
  6. Use of investigational medications within 30 days before study entry or during the trial. (T-20 [enfuvirtide] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)
  7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
  8. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
  9. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144170

  Show 174 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Publications indexed to this study:
Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1182.48, RESIST 2
Study First Received: September 2, 2005
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00144170  
Health Authority: Austria: Bundesministerium fuer soziale Sicherheit und Generationen;   Belgium: Federal Agency for Medicines and Health Products;   Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica;   Switzerland: Swissmedic;   Italy: Comitato Etico della Fondazione Centro San Raffaele del Monte Tabor - Milano;   Portugal: INFARMED I.P.;   United States: Food and Drug Administration

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