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

September 17, 2007
February 24, 2014
August 2006
January 2009   (final data collection date for primary outcome measure)
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.
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 ] [ 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 ]
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00531206
1182.112
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP