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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
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Time Frame 48 weeks
Additional Description No text entered.

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

Serious Adverse Events
    Nevirapine  
Total, serious adverse events    
# participants affected / at risk     12/278 (4.32%)  
Blood and lymphatic system disorders    
Anemia † 1  
# participants affected / at risk     1/278 (0.36%)  
Lymphadenopathy, generalised † 1  
# participants affected / at risk     1/278 (0.36%)  
Pancytopenia † 1  
# participants affected / at risk     1/278 (0.36%)  
Gastrointestinal disorders    
Abdominal pain † 1  
# participants affected / at risk     1/278 (0.36%)  
Cholecystitis † 1  
# participants affected / at risk     1/278 (0.36%)  
Diarrhea † 1  
# participants affected / at risk     1/278 (0.36%)  
Gastroenteritis † 1  
# participants affected / at risk     1/278 (0.36%)  
Melena † 1  
# participants affected / at risk     1/278 (0.36%)  
General disorders    
Fever † 1  
# participants affected / at risk     2/278 (0.72%)  
Malaise † 1  
# participants affected / at risk     1/278 (0.36%)  
Pregnancy † 1  
# participants affected / at risk     1/278 (0.36%)  
Infections and infestations    
Clostridia enteritis † 1  
# participants affected / at risk     1/278 (0.36%)  
Helicobacter phylori infection † 1  
# participants affected / at risk     1/278 (0.36%)  
porta catheter infection † 1  
# participants affected / at risk     1/278 (0.36%)  
Staphylococcus sepsis † 1  
# participants affected / at risk     1/278 (0.36%)  
Injury, poisoning and procedural complications    
Fracture of foot † 1  
# participants affected / at risk     1/278 (0.36%)  
Investigations    
Hyperkaliemia † 1  
# participants affected / at risk     1/278 (0.36%)  
Musculoskeletal and connective tissue disorders    
Chest pain † 1  
# participants affected / at risk     1/278 (0.36%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Lymphoma of the brain † 1  
# participants affected / at risk     1/278 (0.36%)  
Nervous system disorders    
Diabetes insipitus † 1  
# participants affected / at risk     1/278 (0.36%)  
Respiratory, thoracic and mediastinal disorders    
Pneumocystitis † 1  
# participants affected / at risk     1/278 (0.36%)  
Pneumonia † 1  
# participants affected / at risk     2/278 (0.72%)  
Skin and subcutaneous tissue disorders    
Enanthema † 1  
# participants affected / at risk     1/278 (0.36%)  
Herpes eczema † 1  
# participants affected / at risk     1/278 (0.36%)  
Rash † 1  
# participants affected / at risk     1/278 (0.36%)  
Vascular disorders    
Fever † 1  
# participants affected / at risk     1/278 (0.36%)  
Hypertension † 1  
# participants affected / at risk     1/278 (0.36%)  
Pulmonary embolism † 1  
# participants affected / at risk     2/278 (0.72%)  
Shunt thrombosis † 1  
# participants affected / at risk     1/278 (0.36%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1




  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
No text entered.


  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
Poland: Registration Medicinal Product Medical Device Biocidal Product