Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00531206
First received: September 17, 2007
Last updated: February 24, 2014
Last verified: February 2014
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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 ] [ 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
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:
|
Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Ritonavir |
Tipranavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015