Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT00531206
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00531206
Study Brief:
Protocol Section:
NCT00531206