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

Boehringer Ingelheim1 site in 1 country65 target enrollmentAugust 2006

ConditionsHIV Infections

InterventionsTipranavir Ritonavir

DrugsTipranavir Ritonavir

Overview

Phase: Not Applicable
Intervention: Tipranavir
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Enrollment: 65
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

January 2009

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility 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.

Arms & Interventions

All participants

Intervention: Tipranavir

All participants

Intervention: Ritonavir

Outcomes

Primary Outcomes

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 Outcomes

Discontinuations Due to an Adverse Event(52 weeks)
Total Cholesterol Over Time(52 weeks)
CD4+ Cell Count(Baseline and 52 weeks)
Deaths(52 weeks)
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)
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)
Subjective Well-being(52 weeks)
Serious Adverse Events(52 weeks)
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)