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 ]

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

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