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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
Enrollment 334

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Period Title: Overall Study
Started 334
Completed 192
Not Completed 142
Reason Not Completed
Adverse Event             14
Lack of Efficacy             22
Lost to Follow-up             20
not specified             86
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Baseline Participants 334
Hide Baseline Analysis Population Description
FAS - All patients were considered for the full analysis set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 334 participants
41.8  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 334 participants
Female
58
  17.4%
Male
276
  82.6%
1.Primary Outcome
Title Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 295
Median (Inter-Quartile Range)
Unit of Measure: IU/L
1.0
(-3.0 to 7.0)
2.Primary Outcome
Title Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 317
Median (Inter-Quartile Range)
Unit of Measure: IU/L
4.0
(-4.0 to 15.0)
3.Primary Outcome
Title Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 315
Median (Inter-Quartile Range)
Unit of Measure: IU/L
23.0
(9.0 to 59.0)
4.Primary Outcome
Title Summary of Change From Baseline in Creatinine to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 312
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
0.0
(-0.1 to 0.1)
5.Primary Outcome
Title Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 262
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
12.0
(-12.0 to 40.0)
6.Primary Outcome
Title Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 214
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
6.0
(-1.0 to 15.0)
7.Primary Outcome
Title Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 208
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
5.0
(-15.0 to 27.5)
8.Primary Outcome
Title Summary of Change From Baseline in Triglycerides to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 267
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-7.0
(-54.0 to 29.0)
9.Primary Outcome
Title Summary of Change From Baseline in Glucose to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 276
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
0.0
(-8.0 to 8.5)
10.Secondary Outcome
Title Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 311
Median (Inter-Quartile Range)
Unit of Measure: (log10 copies) / ml
-2.3
(-4.53 to 0.0)
11.Secondary Outcome
Title Summary of Change From Baseline in CD4+ Count to Last Value on Treatment
Hide Description [Not Specified]
Time Frame from baseline to last value on treatment in between 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 312
Median (Inter-Quartile Range)
Unit of Measure: (cells) / mm^3
141
(30.5 to 276.5)
12.Secondary Outcome
Title Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description:
Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
Overall Number of Participants Analyzed 334
Measure Type: Number
Unit of Measure: participants
57
13.Secondary Outcome
Title Investigator's Global Clinical Assessment of Patient General Health Status
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS- All patients were considered for the full analysis set.
Arm/Group Title Evaluation Assessment at Baseline Last Evaluation Assessment on Treatment
Hide Arm/Group Description:
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
Overall Number of Participants Analyzed 334 334
Measure Type: Number
Unit of Measure: participants
Good 193 273
Moderate 127 49
Bad 10 4
Missing 4 8
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Treated With Viramune in Combination With Truvada
Hide Arm/Group Description Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
All-Cause Mortality
Patients Treated With Viramune in Combination With Truvada
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients Treated With Viramune in Combination With Truvada
Affected / at Risk (%)
Total   19/334 (5.69%) 
Cardiac disorders   
Myocardial infarction  1  1/334 (0.30%) 
Gastrointestinal disorders   
Anogenital dysplasia  1  1/334 (0.30%) 
Diarrhoea  1  1/334 (0.30%) 
Nausea  1  1/334 (0.30%) 
Rectal ulcer  1  1/334 (0.30%) 
Vomiting  1  1/334 (0.30%) 
General disorders   
Condition aggravated  1  1/334 (0.30%) 
Disease recurrence  1  1/334 (0.30%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/334 (0.30%) 
Hepatitis toxic  1  1/334 (0.30%) 
Jaundice  1  1/334 (0.30%) 
Infections and infestations   
Anogenital warts  1  1/334 (0.30%) 
Meningitis  1  1/334 (0.30%) 
Pilonidal cyst  1  1/334 (0.30%) 
Pneumonia  1  1/334 (0.30%) 
Pulmonary tuberculosis  1  1/334 (0.30%) 
Injury, poisoning and procedural complications   
Face injury  1  1/334 (0.30%) 
Post procedural haemorrhage  1  1/334 (0.30%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/334 (0.30%) 
Intervertebral disc disorder  1  1/334 (0.30%) 
Rotator cuff syndrome  1  1/334 (0.30%) 
Spinal column stenosis  1  1/334 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  1/334 (0.30%) 
Non-Hodgkin's lymphoma  1  1/334 (0.30%) 
Oligodendroglioma  1  1/334 (0.30%) 
Nervous system disorders   
Cerebellar ataxia  1  1/334 (0.30%) 
Dizziness  1  1/334 (0.30%) 
Epilepsy  1  1/334 (0.30%) 
Grand mal convulsion  1  1/334 (0.30%) 
Nervous system disorder  1  1/334 (0.30%) 
Neuromyopathy  1  1/334 (0.30%) 
Nystagmus  1  1/334 (0.30%) 
Post herpetic neuralgia  1  1/334 (0.30%) 
Pregnancy, puerperium and perinatal conditions   
Abortion  1  1/334 (0.30%) 
Psychiatric disorders   
Drug abuse  1  1/334 (0.30%) 
Psychotic disorder  1  1/334 (0.30%) 
Surgical and medical procedures   
Debridement  1  1/334 (0.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Treated With Viramune in Combination With Truvada
Affected / at Risk (%)
Total   19/334 (5.69%) 
Infections and infestations   
Nasopharyngitis  1  19/334 (5.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00543803     History of Changes
Other Study ID Numbers: 1100.1492
First Submitted: October 8, 2007
First Posted: October 15, 2007
Results First Submitted: December 17, 2010
Results First Posted: January 13, 2011
Last Update Posted: May 20, 2014