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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00531206
First Posted: September 18, 2007
Last Update Posted: April 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
September 17, 2007
September 18, 2007
January 28, 2010
May 12, 2010
April 7, 2014
August 2006
January 2009   (Final data collection date for primary outcome measure)
Adverse Events [ Time Frame: 52 weeks ]
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.
Not Provided
Complete list of historical versions of study NCT00531206 on ClinicalTrials.gov Archive Site
  • Change in Viral Load [ Time Frame: Baseline and 52 weeks ]
    Log10 change from baseline in viral load over time
  • CD4+ Cell Count [ Time Frame: Baseline and 52 weeks ]
    Change from baseline in CD4+ count over time
  • Subjective Well-being [ Time Frame: 52 weeks ]
    Investigator's opinion of patient's general condition (quality of life)
  • Serious Adverse Events [ Time Frame: 52 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Use of Lipid Lowering Agents During the Study [ Time Frame: 52 weeks ]
  • Body Mass Index Class (Kilograms/Square Meter) [ Time Frame: 52 weeks ]
  • Total Cholesterol Over Time [ Time Frame: 52 weeks ]
  • High Density Lipoprotein (HDL) Cholesterol Over Time [ Time Frame: 52 weeks ]
  • Low Density Lipoprotein (HDL) Cholesterol Over Time [ Time Frame: 52 weeks ]
  • Triglycerides Over Time [ Time Frame: 52 weeks ]
  • Alanine Aminotransferase (ALT) Over Time [ Time Frame: 52 weeks ]
  • Aspartate Aminotransferase (ALT) Over Time [ Time Frame: 52 weeks ]
  • Gamma-glutamyl Transpeptidase (GGT) Over Time [ Time Frame: 52 weeks ]
  • Creatinine Over Time [ Time Frame: 52 weeks ]
  • Total Bilirubin Over Time [ Time Frame: 52 weeks ]
  • Alkaline Phosphatase Over Time [ Time Frame: 52 weeks ]
Not Provided
Not Provided
Not Provided
 
Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients
HIV Infections
  • Drug: Tipranavir
  • Drug: Ritonavir
    low dose
All participants
Interventions:
  • Drug: Tipranavir
  • Drug: Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
Not Provided
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00531206
1182.112
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014