Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
This study has been completed.
Sponsor:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00531206
First Posted: September 18, 2007
Last Update Posted: April 7, 2014
Information provided by:
Boehringer Ingelheim
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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 ]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 ]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 ]
| 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00531206 History of Changes |
| Other Study ID Numbers: |
1182.112 |
| First Submitted: | September 17, 2007 |
| First Posted: | September 18, 2007 |
| Results First Submitted: | January 28, 2010 |
| Results First Posted: | May 12, 2010 |
| Last Update Posted: | April 7, 2014 |
| Last Verified: | February 2014 |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Tipranavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |