Clinical trial NCT00531206: Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
Official title: Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients

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.


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.

Primary outcomes:
measure: Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in Viral Load
timeFrame: Baseline and 52 weeks
measure: CD4+ Cell Count
timeFrame: Baseline and 52 weeks
measure: Subjective Well-being
timeFrame: 52 weeks
measure: Serious Adverse Events
timeFrame: 52 weeks
measure: Deaths
timeFrame: 52 weeks
measure: Discontinuations Due to an Adverse Event
timeFrame: 52 weeks
measure: Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion
timeFrame: 52 weeks
measure: Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir
timeFrame: 52 weeks
measure: Use of Lipid Lowering Agents During the Study
timeFrame: 52 weeks
measure: Body Mass Index Class (Kilograms/Square Meter)
timeFrame: 52 weeks
measure: Total Cholesterol Over Time
timeFrame: 52 weeks
measure: High Density Lipoprotein (HDL) Cholesterol Over Time
timeFrame: 52 weeks
measure: Low Density Lipoprotein (HDL) Cholesterol Over Time
timeFrame: 52 weeks
measure: Triglycerides Over Time
timeFrame: 52 weeks
measure: Alanine Aminotransferase (ALT) Over Time
timeFrame: 52 weeks
measure: Aspartate Aminotransferase (ALT) Over Time
timeFrame: 52 weeks
measure: Gamma-glutamyl Transpeptidase (GGT) Over Time
timeFrame: 52 weeks
measure: Creatinine Over Time
timeFrame: 52 weeks
measure: Total Bilirubin Over Time
timeFrame: 52 weeks
measure: Alkaline Phosphatase Over Time
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gießen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Halle/Saale
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Homburg/Saar
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Karlsruhe
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Krefeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Magdeburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Oldenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Osnabrück
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wuppertal
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: