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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Geographic Reach

1 country

27 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2007

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

May 12, 2010

Completed

Last Updated

April 7, 2014

Status Verified

February 1, 2014

Enrollment Period

2.4 years

First QC Date

September 17, 2007

Results QC Date

January 28, 2010

Last Update Submit

February 24, 2014

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

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.
52 weeks

Secondary Outcomes (20)

Change in Viral Load
Baseline and 52 weeks
CD4+ Cell Count
Baseline and 52 weeks
Subjective Well-being
52 weeks
Serious Adverse Events
52 weeks
Deaths
52 weeks
+15 more secondary outcomes

Study Arms (1)

All participants

Drug: TipranavirDrug: Ritonavir

Interventions

TipranavirDRUG

All participants

RitonavirDRUG

low dose

All participants

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.