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

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ClinicalTrials.gov Identifier: NCT00543803
Recruitment Status : Completed
First Posted : October 15, 2007
Results First Posted : January 13, 2011
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections

  Participant Flow

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

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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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  

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13


  Serious Adverse Events


  Other Adverse Events


  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