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CLINICAL TRIALS PROFILE FOR APTIVUS

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All Clinical Trials for Aptivus

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00146328	Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects	Completed	Boehringer Ingelheim	Phase 2/Phase 3	2001-04-01	The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.
NCT00344123	Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects	Completed	Boehringer Ingelheim	Phase 1	2007-02-01	Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
NCT00344123	Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects	Completed	Johns Hopkins University	Phase 1	2007-02-01	Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
NCT00517192	Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI	Terminated	Boehringer Ingelheim	Phase 3	2007-09-01	The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.
NCT00531206	Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.	Completed	Boehringer Ingelheim	N/A	2006-08-01	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.
NCT00615290	Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy	Completed	Boehringer Ingelheim	N/A	2007-06-01	To obtain information on clinical practices for patients treated by Aptivus in real life

Clinical Trial Conditions for Aptivus

Condition Name

Condition Name for Aptivus
Intervention	Trials
HIV Infections	7

Condition MeSH

Condition MeSH for Aptivus
Intervention	Trials
HIV Infections	7
Communicable Diseases	1
Infection	1

Clinical Trial Locations for Aptivus

Trials by Country

Trials by Country for Aptivus
Location	Trials
United States	39
Canada	6
Germany	3
France	3
Greece	2

Trials by US State

Trials by US State for Aptivus
Location	Trials
California	3
Maryland	3
Florida	2
Texas	2
North Carolina	2

Clinical Trial Progress for Aptivus

Clinical Trial Phase

Clinical Trial Phase for Aptivus
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Aptivus
Clinical Trial Phase	Trials
Completed	6
Terminated	1

Clinical Trial Sponsors for Aptivus

Sponsor Name

Sponsor Name for Aptivus
Sponsor	Trials
Boehringer Ingelheim	6
Johns Hopkins University	1
University of California, San Diego	1

Sponsor Type

Sponsor Type for Aptivus
Sponsor	Trials
Industry	6
NIH	2
Other	2