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A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00144105
First received: September 2, 2005
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

Successfully screened patients are randomised to open label TPV 500 mg with RTV 100 mg or 200 mg BID or open label LPV 400 mg with RTV 100 mg BID. Background ARV therapy is Tenofovir 300 mg + Lamivudine 300 mg QD in all three treatment groups. The randomisation is stratified by CD4 cell count > 200 cells/µL at screening. The duration of the treatment is 156 weeks.


Condition Intervention Phase
HIV Infections
 Drug: TPV500mg/RTV200mgBID
Drug: TPV500mg/RTV100mgBID
Drug: LPV400mg/RTV100mgBID
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.

Secondary Outcome Measures:
  • Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.

Estimated Enrollment: 540
Study Start Date: February 2004
Estimated Study Completion Date: March 2007
  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. No previous ARV therapy.
  4. Any CD4+ T lymphocyte count < 500 cells / µl.
  5. HIV-1 viral load >= 5000 copies/mL at screening.
  6. Screening laboratory values that indicate adequate baseline organ function.
  7. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening

Exclusion criteria:

  1. 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
  2. Use of investigational medications within 30 days before study entry or during the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144105

  Show 81 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Investigator: Boehringer Ingelheim Study Coordinator
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00144105     History of Changes
Other Study ID Numbers: 1182.33
Study First Received: September 2, 2005
Last Updated: May 23, 2012
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on May 16, 2013