N/A
N=65
Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00531206 ↗Enrolled (actual)
65
Serious AEs
4.6%
Results posted
May 2010
Primary outcome: Primary: Adverse Events — 23 Number of patients with adverse events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tipranavir (Drug); Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
23 | — |
| SECONDARY Change in Viral Load |
-1.56; -1.70; -1.42; -1.42; -1.45 | — |
| SECONDARY CD4+ Cell Count |
30.50; 43.50; 39.50; 63.00; 36.00 | — |
| SECONDARY Subjective Well-being |
23; 35; 7; 0 | — |
| SECONDARY Serious Adverse Events |
3 | — |
| SECONDARY Deaths |
1 | — |
| SECONDARY Discontinuations Due to an Adverse Event |
6 | — |
| SECONDARY Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion |
7 | — |
| SECONDARY Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir |
30; 15; 16; 3; 1 | — |
| SECONDARY Use of Lipid Lowering Agents During the Study |
59; 6 | — |
| SECONDARY Body Mass Index Class (Kilograms/Square Meter) |
2; 62; 0; 1 | — |
| SECONDARY Total Cholesterol Over Time |
213.0; 214.0; 213.0; 217.0; 216.0 | — |
| SECONDARY High Density Lipoprotein (HDL) Cholesterol Over Time |
38.0; 39.0; 39.5; 39.0; 37.0 | — |
| SECONDARY Low Density Lipoprotein (HDL) Cholesterol Over Time |
120.0; 123.0; 125.0; 117.5; 122.0 | — |
| SECONDARY Triglycerides Over Time |
237.5; 256.9; 246.0; 283.4; 265.5 | — |
| SECONDARY Alanine Aminotransferase (ALT) Over Time |
33.0; 31.0; 37.0; 34.0; 37.5 | — |
| SECONDARY Aspartate Aminotransferase (ALT) Over Time |
34.5; 33.5; 40.0; 44.0; 37.5 | — |
| SECONDARY Gamma-glutamyl Transpeptidase (GGT) Over Time |
72.0; 72.0; 72.0; 76.0; 68.0 | — |
| SECONDARY Creatinine Over Time |
0.90; 0.90; 0.90; 0.90; 0.90 | — |
| SECONDARY Total Bilirubin Over Time |
0.42; 0.40; 0.50; 0.50; 0.40 | — |
| SECONDARY Alkaline Phosphatase Over Time |
90.0; 92.5; 87.5; 86.5; 92.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00531206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.