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Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01134939
First received: June 1, 2010
Last updated: January 9, 2015
Last verified: January 2015
Results First Received: December 31, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort
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 Female Patients Female patients who were not pretreated with HIV therapy.
Treatment-naive Male Patients Male patients who were not pretreated with HIV therapy.
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female Patients, Baseline Viral Load Not Documented Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male Patients, Baseline Viral Load Not Documented Male 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 Female Patients   Treatment-naive Male Patients   Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL   Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL   Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL   Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL   Female Patients, Baseline Viral Load Not Documented   Male Patients, Baseline Viral Load Not Documented
STARTED   59   42   51   46   33   14   19   1 
COMPLETED   42   24   41   32   23   5   10   1 
NOT COMPLETED   17   18   10   14   10   9   9   0 
Adverse Event                9                3                4                5                5                5                1                0 
Lack of Efficacy                2                5                1                0                3                0                1                0 
Lost to Follow-up                2                3                0                1                2                1                0                0 
Death                0                1                0                0                0                0                0                0 
Termination page not available                4                6                5                8                0                3                7                0 



  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 study medication and were documented to have taken at least one dose of investigational treatment and of an antiretroviral combination partner.

Reporting Groups
  Description
Treatment-naive Female Patients Female patients who were not pretreated with HIV therapy.
Treatment-naive Male Patients Male patients who were not pretreated with HIV therapy.
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female Patients, Baseline Viral Load Not Documented Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male Patients, Baseline Viral Load Not Documented Male 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 Female Patients   Treatment-naive Male Patients   Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL   Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL   Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL   Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL   Female Patients, Baseline Viral Load Not Documented   Male Patients, Baseline Viral Load Not Documented   Total
Overall Participants Analyzed 
[Units: Participants]
 59   42   51   46   33   14   19   1   265 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.1  (9.7)   39.2  (11.2)   39.2  (9.1)   44.2  (8.1)   36.3  (8.0)   43.2  (10.7)   38.9  (8.9)   50.0   39.7  (9.6) 
Gender 
[Units: Participants]
                 
Female   59   0   51   0   33   0   19   0   162 
Male   0   42   0   46   0   14   0   1   103 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Virologic Response (VR) After 36 Months   [ Time Frame: 36 months ]

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

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

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

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

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

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

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

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

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

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

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

13.  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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01134939     History of Changes
Other Study ID Numbers: 1100.1536
Study First Received: June 1, 2010
Results First Received: December 31, 2014
Last Updated: January 9, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices