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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531206
• Other study ID #: 1182.112
• Status: Completed
• Phase: N/A
• First received: September 17, 2007
• Last updated: February 24, 2014
• Start date: August 2006

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tipranavir

• Ritonavir
low dose

Locations

Country	Name	City	State
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	Köln
Germany	Boehringer Ingelheim Investigational Site	Krefeld
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Viral Load	Log10 change from baseline in viral load over time	Baseline and 52 weeks	No
Secondary	CD4+ Cell Count	Change from baseline in CD4+ count over time	Baseline and 52 weeks	No
Secondary	Subjective Well-being	Investigator's opinion of patient's general condition (quality of life)	52 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir		52 weeks	No
Secondary	Use of Lipid Lowering Agents During the Study		52 weeks	No
Secondary	Body Mass Index Class (Kilograms/Square Meter)		52 weeks	No
Secondary	Total Cholesterol Over Time		52 weeks	No
Secondary	High Density Lipoprotein (HDL) Cholesterol Over Time		52 weeks	No
Secondary	Low Density Lipoprotein (HDL) Cholesterol Over Time		52 weeks	No
Secondary	Triglycerides Over Time		52 weeks	No
Secondary	Alanine Aminotransferase (ALT) Over Time		52 weeks	No
Secondary	Aspartate Aminotransferase (ALT) Over Time		52 weeks	No
Secondary	Gamma-glutamyl Transpeptidase (GGT) Over Time		52 weeks	No
Secondary	Creatinine Over Time		52 weeks	No
Secondary	Total Bilirubin Over Time		52 weeks	No
Secondary	Alkaline Phosphatase Over Time		52 weeks	No

External Links

•   Link