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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Tipranavir; Drug: Ritonavir

• Registration Number: NCT00531206
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-09-17
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Primary Completion: 2009-01
• Results First Submitted: 2010-01-28
• Results First Submitted QC: 2010-04-21
• Results First Posted: 2010-05-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Tipranavir	-
All participants	Ritonavir	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	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

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

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Wuppertal, Germany