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
ClinicalTrials.gov Identifier:
NCT00736502
First received: July 7, 2008
Last updated: February 3, 2014
Last verified: February 2014
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set

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 ]

Measure Type Primary
Measure Title Proportion of Patients Reporting Adverse Events
Measure Description the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.
Time Frame 48 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.

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

Measured Values
    Nevirapine  
Number of Participants Analyzed  
[units: participants]
  278  
Proportion of Patients Reporting Adverse Events  
[units: Percentage¬†of¬†participants]
 
any event     25.5  
serious adverse events     4.3  
adverse events leading to discontinuation     9.7  
rash, any severity     3.2  
hepatic events, any severity     3.2  
Central Nervous system side effects, any severity     3.6  

No statistical analysis provided for Proportion of Patients Reporting Adverse Events



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

Measure Type Secondary
Measure Title Virologic Response (VR)
Measure Description VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.
Time Frame 48 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
TS

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

Measured Values
    Nevirapine  
Number of Participants Analyzed  
[units: participants]
  278  
Virologic Response (VR)  
[units: Participants]
 
with VR     139  
without VR     16  
missing     123  

No statistical analysis provided for Virologic Response (VR)



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

Measure Type Secondary
Measure Title Change in CD4+ Cell Count From Baseline to Week 48
Measure Description Calculated as CD4+ cell count at week 48 minus the baseline value
Time Frame Baseline and week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
TS with non-missing data at baseline and week 48

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

Measured Values
    Nevirapine  
Number of Participants Analyzed  
[units: participants]
  155  
Change in CD4+ Cell Count From Baseline to Week 48  
[units: Cells/mm^3]
Mean ± Standard Deviation
  148.5  ± 154.6  

No statistical analysis provided for Change in CD4+ Cell Count From Baseline to Week 48




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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
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: February 3, 2014
Health Authority: Austria: Agency for Health and Food Safety
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