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
ClinicalTrials.gov Identifier:
NCT00979420
First received: September 16, 2009
Last updated: June 27, 2014
Last verified: June 2014
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
No text entered.

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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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 - all patients receiving at least one dose of study medication

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

7.  Secondary:   Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade   [ Time Frame: Up to 185 months ]

8.  Secondary:   Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

9.  Secondary:   Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

10.  Secondary:   Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

11.  Secondary:   Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

12.  Secondary:   Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

13.  Secondary:   Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

14.  Secondary:   Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

15.  Secondary:   Duration of Intake of Viramune   [ Time Frame: End of treatment, up to 185 months ]

16.  Secondary:   History of Therapy With Antiretroviral Medication   [ Time Frame: Baseline ]

17.  Secondary:   Course of Absolute CD4+ Cell Count   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months ]

18.  Secondary:   Number of Participants With Drug Related Adverse Events   [ Time Frame: Up to 185 months ]


  Serious Adverse Events
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Time Frame 14 to 185 months
Additional Description No text entered.

Reporting Groups
  Description
Viramune No text entered.

Serious Adverse Events
    Viramune  
Total, serious adverse events    
# participants affected / at risk     35/356 (9.83%)  
Cardiac disorders    
Acute myocardial infarction † 1  
# participants affected / at risk     1/356 (0.28%)  
Bradycardia † 1  
# participants affected / at risk     1/356 (0.28%)  
Cardiac valve disease † 1  
# participants affected / at risk     1/356 (0.28%)  
Congestive cardiomyopathy † 1  
# participants affected / at risk     1/356 (0.28%)  
Coronary artery disease † 1  
# participants affected / at risk     2/356 (0.56%)  
Coronary artery occlusion † 1  
# participants affected / at risk     1/356 (0.28%)  
Coronary artery stenosis † 1  
# participants affected / at risk     1/356 (0.28%)  
Myocardial infarction † 1  
# participants affected / at risk     8/356 (2.25%)  
Gastrointestinal disorders    
Abdominal pain lower † 1  
# participants affected / at risk     1/356 (0.28%)  
Pancreatitis † 1  
# participants affected / at risk     1/356 (0.28%)  
Subileus † 1  
# participants affected / at risk     1/356 (0.28%)  
Umbilical hernia † 1  
# participants affected / at risk     1/356 (0.28%)  
Vomiting † 1  
# participants affected / at risk     1/356 (0.28%)  
Infections and infestations    
Appendicitis † 1  
# participants affected / at risk     2/356 (0.56%)  
Pneumonia pneumococcal † 1  
# participants affected / at risk     1/356 (0.28%)  
Syphilis † 1  
# participants affected / at risk     1/356 (0.28%)  
Injury, poisoning and procedural complications    
Accident † 1  
# participants affected / at risk     1/356 (0.28%)  
Spinal cord injury † 1  
# participants affected / at risk     1/356 (0.28%)  
Musculoskeletal and connective tissue disorders    
Osteonecrosis † 1  
# participants affected / at risk     1/356 (0.28%)  
Rotator cuff syndrome † 1  
# participants affected / at risk     1/356 (0.28%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Colon cancer † 1  
# participants affected / at risk     1/356 (0.28%)  
Nervous system disorders    
Cerebral haemorrhage † 1  
# participants affected / at risk     1/356 (0.28%)  
Cerebral ischaemia † 1  
# participants affected / at risk     1/356 (0.28%)  
Grand mal convulsion † 1  
# participants affected / at risk     1/356 (0.28%)  
Headache † 1  
# participants affected / at risk     1/356 (0.28%)  
Hemiparesis † 1  
# participants affected / at risk     1/356 (0.28%)  
Pregnancy, puerperium and perinatal conditions    
Abortion † 1  
# participants affected / at risk     2/356 (0.56%)  
Abortion spontaneous † 1  
# participants affected / at risk     5/356 (1.40%)  
Premature baby † 1  
# participants affected / at risk     1/356 (0.28%)  
Psychiatric disorders    
Substance abuse † 1  
# participants affected / at risk     1/356 (0.28%)  
Suicide attempt † 1  
# participants affected / at risk     2/356 (0.56%)  
Respiratory, thoracic and mediastinal disorders    
Pulmonary embolism † 1  
# participants affected / at risk     1/356 (0.28%)  
Surgical and medical procedures    
Caesarean section † 1  
# participants affected / at risk     7/356 (1.97%)  
Vascular disorders    
Venous thrombosis † 1  
# participants affected / at risk     2/356 (0.56%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1




  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
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