PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00736502

First received: July 7, 2008

Last updated: September 13, 2012

Last verified: September 2012

History of Changes

Results First Received: July 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
There were 280 patients enrolled but two patients were lost to follow up before the second visit (2 weeks). For these two patients no information about Nevirapine intake could be assessed. So they were not included in the treated set which was used for most of the analyses.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an observational, non-interventional, uncontrolled, prospective post marketing study.

Reporting Groups

	Description
Nevirapine	Patients treated with 200 mg Nevirapine twice daily (administered orally).

Participant Flow: Overall Study

	Nevirapine
STARTED	278 ^[1]
COMPLETED	213
NOT COMPLETED	65
Adverse Event	22
Lack of Efficacy	16
Lost to Follow-up	27

[1]	Entered and treated.

Baseline Characteristics

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Reporting Groups

	Description
Nevirapine	Patients treated with 200 mg Nevirapine twice daily (administered orally).

Baseline Measures

	Nevirapine
Number of Participants [units: participants]	278
Age [units: Years] Mean ± Standard Deviation	38.5 ± 10.3
Gender [units: Participants]
Female	59
Male	219

Outcome Measures

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1. Primary:

Proportion of Patients Reporting Adverse Events [ Time Frame: 48 weeks ]

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2. Secondary:

Virologic Response (VR) [ Time Frame: 48 weeks ]

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3. Secondary:

Change in CD4+ Cell Count From Baseline to Week 48 [ Time Frame: Baseline and week 48 ]

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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
No text entered.

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:	NCT00736502 History of Changes
Other Study ID Numbers:	1100.1527
Study First Received:	July 7, 2008
Results First Received:	July 30, 2012
Last Updated:	September 13, 2012
Health Authority:	Austria: Agency for Health and Food Safety Poland: Registration Medicinal Product Medical Device Biocidal Product

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