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
ClinicalTrials.gov Identifier:
NCT00543803
First received: October 8, 2007
Last updated: May 13, 2014
Last verified: May 2014
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 Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, 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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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.
FAS - All patients were considered for the full analysis set.

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]
  Hide Outcome Measure 7

Measure Type Primary
Measure Title Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
Measure Description The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
Time Frame from baseline to last value on treatment in between 36 months  
Safety Issue No  

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.
FAS- All patients were considered for the full analysis set.

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

Measured Values
    Patients Treated With Viramune in Combination With Truvada  
Number of Participants Analyzed  
[units: participants]
  208  
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment  
[units: mg/dl]
Median ( Inter-Quartile Range )
  5.0  
  ( -15.0 to 27.5 )  

No statistical analysis provided for Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment



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 ]

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 ]

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 ]

11.  Secondary:   Summary of Change From Baseline in CD4+ Count to Last Value on Treatment   [ Time Frame: from baseline to last value on treatment in between 36 months ]

12.  Secondary:   Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator   [ Time Frame: from baseline to last value on treatment in between 36 months ]

13.  Secondary:   Investigator's Global Clinical Assessment of Patient General Health Status   [ Time Frame: from baseline to last value on treatment in between 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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