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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tipranavir
* Drug: Ritonavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br> | Drug: Tipranavir<br> <br> Drug: Ritonavir<br>* low dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | 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. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Viral Load | Log10 change from baseline in viral load over time | Baseline and 52 weeks | 
| CD4+ Cell Count | Change from baseline in CD4+ count over time | Baseline and 52 weeks | 
| Subjective Well-being | Investigator's opinion of patient's general condition (quality of life) | 52 weeks | 
| Serious Adverse Events | 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. | 52 weeks | 
| Deaths | 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. | 52 weeks | 
| Discontinuations Due to an Adverse Event | 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. | 52 weeks | 
| Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion | 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. | 52 weeks | 
| Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir |  | 52 weeks | 
| Use of Lipid Lowering Agents During the Study |  | 52 weeks | 
| Body Mass Index Class (Kilograms/Square Meter) |  | 52 weeks | 
| Total Cholesterol Over Time |  | 52 weeks | 
| High Density Lipoprotein (HDL) Cholesterol Over Time |  | 52 weeks | 
| Low Density Lipoprotein (HDL) Cholesterol Over Time |  | 52 weeks | 
| Triglycerides Over Time |  | 52 weeks | 
| Alanine Aminotransferase (ALT) Over Time |  | 52 weeks | 
| Aspartate Aminotransferase (ALT) Over Time |  | 52 weeks | 
| Gamma-glutamyl Transpeptidase (GGT) Over Time |  | 52 weeks | 
| Creatinine Over Time |  | 52 weeks | 
| Total Bilirubin Over Time |  | 52 weeks | 
| Alkaline Phosphatase Over Time |  | 52 weeks |