A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00976950

First received: September 14, 2009

Last updated: January 31, 2013

Last verified: January 2013

History of Changes

Results First Received: May 30, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; 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 and Ritonavir	TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Participant Flow: Overall Study

	Aptivus and Ritonavir
STARTED	42
COMPLETED	36
NOT COMPLETED	6
Adverse Event	3
Events with no relationship to Aptivus	3

Baseline Characteristics

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Reporting Groups

	Description
Aptivus and Ritonavir	TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Baseline Measures

	Aptivus and Ritonavir
Number of Participants [units: participants]	42
Age ^[1] [units: years] Mean ± Standard Deviation	25.5 ± 10.4
Gender [units: Number]
Female	19
Male	23
Baseline HIV RNA values [units: Participants]
<= 50 copies/ml	0
51 - <1,000 copies/ml	1
1,000 - <10,000 copies/ml	5
10,000 - <100,000 copies/ml	13
100,000 - <1,000,000 copies/ml	12
>= 1,000,000 copies/ml	0
Missing	11
Baseline CD4+ count [units: Participants]
<= 50 cells/mm^3	2
51 - <251 cells/mm^3	19
251 - <451 cells/mm^3	13
>= 451 cells/mm^3	8

[1]	Age is available for 41 patients.

Outcome Measures

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1. Primary:

Number of Patients Reporting Adverse Events (AE) [ Time Frame: 48 weeks ]

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2. Secondary:

Virologic Response [ Time Frame: 48 weeks ]

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3. Secondary:

Change in CD4+ Cell Count From Baseline at Week 48 [ Time Frame: 48 weeks ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Aptivus and Ritonavir	ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir

Serious Adverse Events

	Aptivus and Ritonavir
Total, serious adverse events
# participants affected / at risk	1/42 (2.38%)
Infections and infestations
Pulmonary tuberculosis ^{† 1}
# participants affected / at risk	1/42 (2.38%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA Version 14.0

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 Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00976950 History of Changes
Other Study ID Numbers:	1182.147
Study First Received:	September 14, 2009
Results First Received:	May 30, 2012
Last Updated:	January 31, 2013
Health Authority:	Romania: National Medicines Agency

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