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

Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00531206

Enrollment

Registered

2007-09-18

Start date

2006-08-31

Completion date

Unknown

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGTipranavir

DRUGRitonavir

low dose

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	52 weeks	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.

Secondary

Measure	Time frame	Description
CD4+ Cell Count	Baseline and 52 weeks	Change from baseline in CD4+ count over time
Subjective Well-being	52 weeks	Investigator's opinion of patient's general condition (quality of life)
Serious Adverse Events	52 weeks	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.
Deaths	52 weeks	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.
Discontinuations Due to an Adverse Event	52 weeks	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.
Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion	52 weeks	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.
Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir	52 weeks	—
Use of Lipid Lowering Agents During the Study	52 weeks	—
Body Mass Index Class (Kilograms/Square Meter)	52 weeks	—
Change in Viral Load	Baseline and 52 weeks	Log10 change from baseline in viral load over time
High Density Lipoprotein (HDL) Cholesterol Over Time	52 weeks	—
Low Density Lipoprotein (HDL) Cholesterol Over Time	52 weeks	—
Triglycerides Over Time	52 weeks	—
Alanine Aminotransferase (ALT) Over Time	52 weeks	—
Aspartate Aminotransferase (ALT) Over Time	52 weeks	—
Gamma-glutamyl Transpeptidase (GGT) Over Time	52 weeks	—
Creatinine Over Time	52 weeks	—
Total Bilirubin Over Time	52 weeks	—
Alkaline Phosphatase Over Time	52 weeks	—
Total Cholesterol Over Time	52 weeks	—

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Aptivus® in Combination With Low-dose Norvir® Aptivus® in combination with low-dose Norvir® and optimised backbone therapy	65
Total	65

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event related	5
Overall Study	including non-related adverse events	8
Overall Study	Lack of Efficacy	2
Overall Study	Lost to Follow-up	5

Baseline characteristics

Characteristic	Aptivus® in Combination With Low-dose Norvir®
Age, Continuous	45.9 Years STANDARD_DEVIATION 8.8
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	59 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	4 / 65
serious Total, serious adverse events	3 / 65

Outcome results

Primary

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