Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00531206
First received: September 17, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.


Condition Intervention
HIV Infections
Drug: Tipranavir
Drug: Ritonavir

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.


Secondary Outcome Measures:
  • Change in Viral Load [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Log10 change from baseline in viral load over time

  • CD4+ Cell Count [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in CD4+ count over time

  • Subjective Well-being [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Investigator's opinion of patient's general condition (quality of life)

  • Serious Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  • Deaths [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  • Discontinuations Due to an Adverse Event [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  • Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.

  • Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Use of Lipid Lowering Agents During the Study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Body Mass Index Class (Kilograms/Square Meter) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Total Cholesterol Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • High Density Lipoprotein (HDL) Cholesterol Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Low Density Lipoprotein (HDL) Cholesterol Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Triglycerides Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Alanine Aminotransferase (ALT) Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Aspartate Aminotransferase (ALT) Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Gamma-glutamyl Transpeptidase (GGT) Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Creatinine Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Total Bilirubin Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Alkaline Phosphatase Over Time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: August 2006
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants Drug: Tipranavir Drug: Ritonavir
low dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients

Criteria

Inclusion Criteria:

Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.

Exclusion Criteria:

  • Age < 18 years
  • pregnant female patients
  • Hypersensitivity to the active substance or to any of the excipients.
  • Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
  • Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
  • Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
  • Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531206

Locations
Germany
Boehringer Ingelheim Investigational Site
Aachen, Germany
Boehringer Ingelheim Investigational Site
Berlin, Germany
Boehringer Ingelheim Investigational Site
Bremen, Germany
Boehringer Ingelheim Investigational Site
Dortmund, Germany
Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
Boehringer Ingelheim Investigational Site
Erlangen, Germany
Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
Boehringer Ingelheim Investigational Site
Freiburg, Germany
Boehringer Ingelheim Investigational Site
Gießen, Germany
Boehringer Ingelheim Investigational Site
Halle/Saale, Germany
Boehringer Ingelheim Investigational Site
Hamburg, Germany
Boehringer Ingelheim Investigational Site
Hannover, Germany
Boehringer Ingelheim Investigational Site
Homburg/Saar, Germany
Boehringer Ingelheim Investigational Site
Karlsruhe, Germany
Boehringer Ingelheim Investigational Site
Krefeld, Germany
Boehringer Ingelheim Investigational Site
Köln, Germany
Boehringer Ingelheim Investigational Site
Leipzig, Germany
Boehringer Ingelheim Investigational Site
Magdeburg, Germany
Boehringer Ingelheim Investigational Site
Mainz, Germany
Boehringer Ingelheim Investigational Site
München, Germany
Boehringer Ingelheim Investigational Site
Münster, Germany
Boehringer Ingelheim Investigational Site
Nürnberg, Germany
Boehringer Ingelheim Investigational Site
Oldenburg, Germany
Boehringer Ingelheim Investigational Site
Osnabrück, Germany
Boehringer Ingelheim Investigational Site
Saarbrücken, Germany
Boehringer Ingelheim Investigational Site
Stuttgart, Germany
Boehringer Ingelheim Investigational Site
Wuppertal, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00531206     History of Changes
Other Study ID Numbers: 1182.112
Study First Received: September 17, 2007
Results First Received: January 28, 2010
Last Updated: February 24, 2014
Health Authority: Germany:

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

ClinicalTrials.gov processed this record on September 18, 2014