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

Boehringer Ingelheim65 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Infections

Interventions

TipranavirDRUG

RitonavirDRUG

low dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (27)

Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: 52 weeks

Secondary Outcomes

Change in Viral Load

Log10 change from baseline in viral load over time

Time frame: Baseline and 52 weeks

CD4+ Cell Count

Change from baseline in CD4+ count over time

Time frame: Baseline and 52 weeks

Subjective Well-being

Investigator's opinion of patient's general condition (quality of life)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 52 weeks

Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion

Data from ClinicalTrials.gov

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