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Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00876733
First received: March 20, 2009
Last updated: January 14, 2015
Last verified: January 2015
Results First Received: December 27, 2014  
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
Treatment-naive Patients Patients who were not pretreated with HIV therapy.
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients With Baseline Viral Load Not Documented Patients who could not be assigned to one of the three subgroups and had no documented viral load value.

Participant Flow:   Overall Study
    Treatment-naive Patients     Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL     Pretreated Patients, Baseline Viral Load > 50 Copies/mL     Patients With Baseline Viral Load Not Documented  
STARTED     288     203     93     21  
COMPLETED     197     161     63     14  
NOT COMPLETED     91     42     30     7  
Adverse Event                 34                 20                 10                 3  
Lack of Efficacy                 17                 9                 10                 1  
Lost to Follow-up                 26                 10                 3                 2  
Data not available                 14                 3                 7                 1  



  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 (TS): This patient set includes all HIV-1 infected patients who were dispensed Viramune® and were documented to have taken at least one dose of Viramune®and of a antiretroviral combination partner.

Reporting Groups
  Description
Treatment-naive Patients Patients who were not pretreated with HIV therapy.
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients With Baseline Viral Load Not Documented Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Total Total of all reporting groups

Baseline Measures
    Treatment-naive Patients     Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL     Pretreated Patients, Baseline Viral Load > 50 Copies/mL     Patients With Baseline Viral Load Not Documented     Total  
Number of Participants  
[units: participants]
  288     203     93     21     605  
Age  
[units: years]
Mean ± Standard Deviation
  40.2  ± 9.9     43.8  ± 9.6     40.9  ± 9.4     43.6  ± 7.8     41.6  ± 9.8  
Gender  
[units: participants]
         
Female     32     29     6     0     67  
Male     256     174     87     21     538  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs   [ Time Frame: 36 months ]

2.  Secondary:   Changes in the Viral Load After 12 Months From Baseline.   [ Time Frame: Baseline and 12 months ]

3.  Secondary:   Changes in the Viral Load After 36 Months From Baseline.   [ Time Frame: Baseline and 36 months ]

4.  Secondary:   Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.   [ Time Frame: Baseline and 12 months ]

5.  Secondary:   Changes in the CD4+ Cell Count After 36 Months From Baseline.   [ Time Frame: Baseline and 36 months ]

6.  Secondary:   Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

7.  Secondary:   Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

8.  Secondary:   Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

9.  Secondary:   Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

10.  Secondary:   Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

11.  Secondary:   Changes in the Laboratory Data (ALT) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

12.  Secondary:   Changes in the Laboratory Data (AST) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

13.  Secondary:   Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

14.  Secondary:   Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

15.  Secondary:   Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline   [ Time Frame: Baseline and 12 months ]

16.  Secondary:   Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

17.  Secondary:   Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

18.  Secondary:   Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

19.  Secondary:   Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

20.  Secondary:   Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

21.  Secondary:   Changes in the Laboratory Data (ALT) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

22.  Secondary:   Changes in the Laboratory Data (AST) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

23.  Secondary:   Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

24.  Secondary:   Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]

25.  Secondary:   Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline   [ Time Frame: Baseline and 36 months ]


  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: NCT00876733     History of Changes
Other Study ID Numbers: 1100.1524
Study First Received: March 20, 2009
Results First Received: December 27, 2014
Last Updated: January 14, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices