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Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00543803
First received: October 8, 2007
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: December 17, 2010  
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
Patients Treated With Viramune in Combination With Truvada 200mg bid for two weeks, then 200mg qd, Truvada one tablet qd

Participant Flow:   Overall Study
    Patients Treated With Viramune in Combination With Truvada  
STARTED     334  
COMPLETED     192  
NOT COMPLETED     142  
Adverse Event                 14  
Lack of Efficacy                 22  
Lost to Follow-up                 20  
not specified                 86  



  Baseline Characteristics
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Reporting Groups
  Description
Patients Treated With Viramune in Combination With Truvada 200mg bid for two weeks, then 200mg qd, Truvada one tablet qd

Baseline Measures
    Patients Treated With Viramune in Combination With Truvada  
Number of Participants  
[units: participants]
 		  334  
Age  
[units: Years]
Mean ± Standard Deviation 		  41.8  ± 9.8  
Gender  
[units: Participants]
 		 
Female     58  
Male     276  



  Outcome Measures
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1.  Primary:   Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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2.  Primary:   Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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3.  Primary:   Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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4.  Primary:   Summary of Change From Baseline in Creatinine to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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5.  Primary:   Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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6.  Primary:   Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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7.  Primary:   Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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8.  Primary:   Summary of Change From Baseline in Triglycerides to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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9.  Primary:   Summary of Change From Baseline in Glucose to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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10.  Secondary:   Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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11.  Secondary:   Summary of Log10 Change From Baseline in CD4+ Count to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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