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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
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
No text entered.

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
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 
Overall Participants Analyzed 
[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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
Measure Description The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
Time Frame from baseline to last value on treatment in between 36 months  
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.
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 
Participants Analyzed 
[Units: Participants]
 295 
Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment 
[Units: IU/L]
Median (Inter-Quartile Range)
 1.0 
 (-3.0 to 7.0) 

No statistical analysis provided for Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment



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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
Measure Description The change in asparate aminotransferase (AST) from baseline to the last value in treatment
Time Frame from baseline to last value on treatment in between 36 months  
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.
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 
Participants Analyzed 
[Units: Participants]
 317 
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment 
[Units: IU/L]
Median (Inter-Quartile Range)
 4.0 
 (-4.0 to 15.0) 

No statistical analysis provided for Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment



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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
Measure Description The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
Time Frame from baseline to last value on treatment in between 36 months  
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.
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 
Participants Analyzed 
[Units: Participants]
 315 
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment 
[Units: IU/L]
Median (Inter-Quartile Range)
 23.0 
 (9.0 to 59.0) 

No statistical analysis provided for Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment



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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in Creatinine to Last Value on Treatment
Measure Description The change in Creatinine 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 
Participants Analyzed 
[Units: Participants]
 312 
Summary of Change From Baseline in Creatinine to Last Value on Treatment 
[Units: Mg/dl]
Median (Inter-Quartile Range)
 0.0 
 (-0.1 to 0.1) 

No statistical analysis provided for Summary of Change From Baseline in Creatinine to Last Value on Treatment



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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
Measure Description The change in total 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 
Participants Analyzed 
[Units: Participants]
 262 
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment 
[Units: Mg/dl]
Median (Inter-Quartile Range)
 12.0 
 (-12.0 to 40.0) 

No statistical analysis provided for Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment



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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
Measure Description The change in High-density lipoprotein (HDL) 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 
Participants Analyzed 
[Units: Participants]
 214 
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment 
[Units: Mg/dl]
Median (Inter-Quartile Range)
 6.0 
 (-1.0 to 15.0) 

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



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 ]

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 
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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in Triglycerides to Last Value on Treatment
Measure Description The change in triglycerides 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 
Participants Analyzed 
[Units: Participants]
 267 
Summary of Change From Baseline in Triglycerides to Last Value on Treatment 
[Units: Mg/dl]
Median (Inter-Quartile Range)
 -7.0 
 (-54.0 to 29.0) 

No statistical analysis provided for Summary of Change From Baseline in Triglycerides to Last Value on Treatment



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 ]

Measure Type Primary
Measure Title Summary of Change From Baseline in Glucose to Last Value on Treatment
Measure Description The change in Glucose 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 
Participants Analyzed 
[Units: Participants]
 276 
Summary of Change From Baseline in Glucose to Last Value on Treatment 
[Units: Mg/dl]
Median (Inter-Quartile Range)
 0.0 
 (-8.0 to 8.5) 

No statistical analysis provided for Summary of Change From Baseline in Glucose to Last Value on Treatment



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 ]

Measure Type Secondary
Measure Title Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment
Measure Description For calculation of this measure switch patients are included in the total which had no viral load decrease.
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 
Participants Analyzed 
[Units: Participants]
 311 
Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment 
[Units: (log10 copies) / ml]
Median (Inter-Quartile Range)
 -2.3 
 (-4.53 to 0.0) 

No statistical analysis provided for Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment



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 ]

Measure Type Secondary
Measure Title Summary of Change From Baseline in CD4+ Count to Last Value on Treatment
Measure Description No text entered.
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 
Participants Analyzed 
[Units: Participants]
 312 
Summary of Change From Baseline in CD4+ Count to Last Value on Treatment 
[Units: (cells) / mm^3]
Median (Inter-Quartile Range)
 141 
 (30.5 to 276.5) 

No statistical analysis provided for Summary of Change From Baseline in CD4+ Count to Last Value on Treatment



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 ]

Measure Type Secondary
Measure Title Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator
Measure Description Total number of patients with investigator defined non-serious drug-related AEs was reported.
Time Frame from baseline to last value on treatment in between 36 months  
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.
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 
Participants Analyzed 
[Units: Participants]
 334 
Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator 
[Units: Participants]
 57 

No statistical analysis provided for Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator



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 ]

Measure Type Secondary
Measure Title Investigator's Global Clinical Assessment of Patient General Health Status
Measure Description Investigators opinion of patients general health condition at baseline versus last evaluation on 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
Evaluation Assessment at Baseline Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
Last Evaluation Assessment on Treatment Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)

Measured Values
   Evaluation Assessment at Baseline   Last Evaluation Assessment on Treatment 
Participants Analyzed 
[Units: Participants]
 334   334 
Investigator's Global Clinical Assessment of Patient General Health Status 
[Units: Participants]
   
Good   193   273 
Moderate   127   49 
Bad   10   4 
Missing   4   8 

No statistical analysis provided for Investigator's Global Clinical Assessment of Patient General Health Status




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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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  More Information