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

Boehringer Ingelheim

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Tipranavir; Drug: Ritonavir

Study type: Observational

Funder types: Industry

Identifiers

NCT00531206

1182.112

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

65 participants in 1 patient group

All participants

Treatment:

Drug: Tipranavir

Drug: Ritonavir