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

This study has been completed.

Study NCT00531206 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on September 17, 2007. Last Updated on May 18, 2012 History of Changes

Results First Received: January 28, 2010

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	HIV Infections

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Aptivus® in Combination With Low-dose Norvir®	Aptivus® in combination with low-dose Norvir® and optimised backbone therapy

Participant Flow: Overall Study

	Aptivus® in Combination With Low-dose Norvir®
STARTED	65
COMPLETED	45
NOT COMPLETED	20
Adverse Event related	5
Lack of Efficacy	2
Lost to Follow-up	5
including non-related adverse events	8

Baseline Characteristics

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Reporting Groups

	Description
Aptivus® in Combination With Low-dose Norvir®	Aptivus® in combination with low-dose Norvir® and optimised backbone therapy

Baseline Measures

	Aptivus® in Combination With Low-dose Norvir®
Number of Participants [units: participants]	65
Age [units: Years] Mean ± Standard Deviation	45.9 ± 8.8
Gender [units: participants]
Female	6
Male	59

Outcome Measures

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1. Primary:

Adverse Events [ Time Frame: 52 weeks ]

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2. Secondary:

Change in Viral Load [ Time Frame: Baseline and 52 weeks ]

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3. Secondary:

CD4+ Cell Count [ Time Frame: Baseline and 52 weeks ]

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4. Secondary:

Subjective Well-being [ Time Frame: 52 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00531206 History of Changes
Other Study ID Numbers:	1182.112
Study First Received:	September 17, 2007
Results First Received:	January 28, 2010
Last Updated:	May 18, 2012
Health Authority:	Germany: