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Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00979420
First received: September 16, 2009
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: May 30, 2012  
Study Type: Observational
Study Design: Time Perspective: Retrospective
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 Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Participant Flow:   Overall Study
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA <50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
STARTED     178     57     60     61  
COMPLETED     171     57     59     59  
NOT COMPLETED     7     0     1     2  
Adverse Event                 1                 0                 0                 0  
Lack of Efficacy                 3                 0                 1                 1  
Other reasons not related to Viramune                 3                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune
Total Total of all reporting groups

Baseline Measures
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented     Total  
Number of Participants  
[units: participants]
 		  178     57     60     61     356  
Age  
[units: Years]
Mean ± Standard Deviation 		  50.85  ± 10.54     54.21  ± 10.42     51.02  ± 7.66     53.69  ± 11.05     51.91  ± 10.24  
Gender, Customized  
[units: Participants]
 		         
Male     142     44     41     51     278  
Female     36     13     19     9     77  
Missing     0     0     0     1     1  



  Outcome Measures
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1.  Primary:   Change in log10 Viral Load From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]
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2.  Primary:   Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit   [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]
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3.  Primary:   Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]
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4.  Primary:   Change in log10 Viral Load From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]
  Show Outcome Measure 4

5.  Primary:   Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit   [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]
  Show Outcome Measure 5

6.  Primary:   Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]
  Show Outcome Measure 6

7.  Secondary:   Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade   [ Time Frame: 15 years ]
  Show Outcome Measure 7

8.  Secondary:   Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade   [ Time Frame: 15 years ]
  Show Outcome Measure 8

9.  Secondary:   Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade   [ Time Frame: 15 years ]
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10.  Secondary:   Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade   [ Time Frame: 15 years ]
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11.  Secondary:   Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: 15 years ]
  Show Outcome Measure 11

12.  Secondary:   Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: 15 years ]
  Show Outcome Measure 12

13.  Secondary:   Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade   [ Time Frame: 15 years ]
  Hide Outcome Measure 13

Measure Type Secondary
Measure Title Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
Measure Description Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Time Frame 15 years  
Safety Issue Yes  

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.
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.

Reporting Groups
  Description
Treatment-naive Patients Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values
    Treatment-naive Patients     Pre-treated Patients With Baseline HIV RNA<50 Copies/ml     Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml     Pre-treated Patients With Baseline HIV RNA Not Documented  
Number of Participants Analyzed  
[units: participants]
 		  178     57     60     59  
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade  
[units: Participants]
 		       
< Grade 1     152     51     50     49  
Grade 1     13     3     5     3  
Grade 2     2     0     2     1  
Grade 3     1     0     0     1  
Grade 4     10     3     3     5  

No statistical analysis provided for Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade



14.  Secondary:   Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade   [ Time Frame: 15 years ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00979420     History of Changes
Other Study ID Numbers: 1100.1535
Study First Received: September 16, 2009
Results First Received: May 30, 2012
Last Updated: July 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices