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  
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 ]

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
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Time Frame 36 months
Additional Description No text entered.

Reporting Groups
  Description
Patients Treated With Viramune in Combination With Truvada Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD

Serious Adverse Events
    Patients Treated With Viramune in Combination With Truvada  
Total, serious adverse events    
# participants affected / at risk     19/334 (5.69%)  
Cardiac disorders    
Myocardial infarction † 1  
# participants affected / at risk     1/334 (0.30%)  
Gastrointestinal disorders    
Anogenital dysplasia † 1  
# participants affected / at risk     1/334 (0.30%)  
Diarrhoea † 1  
# participants affected / at risk     1/334 (0.30%)  
Nausea † 1  
# participants affected / at risk     1/334 (0.30%)  
Rectal ulcer † 1  
# participants affected / at risk     1/334 (0.30%)  
Vomiting † 1  
# participants affected / at risk     1/334 (0.30%)  
General disorders    
Condition aggravated † 1  
# participants affected / at risk     1/334 (0.30%)  
Disease recurrence † 1  
# participants affected / at risk     1/334 (0.30%)  
Hepatobiliary disorders    
Cholelithiasis † 1  
# participants affected / at risk     1/334 (0.30%)  
Hepatitis toxic † 1  
# participants affected / at risk     1/334 (0.30%)  
Jaundice † 1  
# participants affected / at risk     1/334 (0.30%)  
Infections and infestations    
Anogenital warts † 1  
# participants affected / at risk     1/334 (0.30%)  
Meningitis † 1  
# participants affected / at risk     1/334 (0.30%)  
Pilonidal cyst † 1  
# participants affected / at risk     1/334 (0.30%)  
Pneumonia † 1  
# participants affected / at risk     1/334 (0.30%)  
Pulmonary tuberculosis † 1  
# participants affected / at risk     1/334 (0.30%)  
Injury, poisoning and procedural complications    
Face injury † 1  
# participants affected / at risk     1/334 (0.30%)  
Post procedural haemorrhage † 1  
# participants affected / at risk     1/334 (0.30%)  
Musculoskeletal and connective tissue disorders    
Back pain † 1  
# participants affected / at risk     1/334 (0.30%)  
Intervertebral disc disorder † 1  
# participants affected / at risk     1/334 (0.30%)  
Rotator cuff syndrome † 1  
# participants affected / at risk     1/334 (0.30%)  
Spinal column stenosis † 1  
# participants affected / at risk     1/334 (0.30%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Colon cancer † 1  
# participants affected / at risk     1/334 (0.30%)  
Non-Hodgkin's lymphoma † 1  
# participants affected / at risk     1/334 (0.30%)  
Oligodendroglioma † 1  
# participants affected / at risk     1/334 (0.30%)  
Nervous system disorders    
Cerebellar ataxia † 1  
# participants affected / at risk     1/334 (0.30%)  
Dizziness † 1  
# participants affected / at risk     1/334 (0.30%)  
Epilepsy † 1  
# participants affected / at risk     1/334 (0.30%)  
Grand mal convulsion † 1  
# participants affected / at risk     1/334 (0.30%)  
Nervous system disorder † 1  
# participants affected / at risk     1/334 (0.30%)  
Neuromyopathy † 1  
# participants affected / at risk     1/334 (0.30%)  
Nystagmus † 1  
# participants affected / at risk     1/334 (0.30%)  
Post herpetic neuralgia † 1  
# participants affected / at risk     1/334 (0.30%)  
Pregnancy, puerperium and perinatal conditions    
Abortion † 1  
# participants affected / at risk     1/334 (0.30%)  
Psychiatric disorders    
Drug abuse † 1  
# participants affected / at risk     1/334 (0.30%)  
Psychotic disorder † 1  
# participants affected / at risk     1/334 (0.30%)  
Surgical and medical procedures    
Debridement † 1  
# participants affected / at risk     1/334 (0.30%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0




  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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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00543803     History of Changes
Other Study ID Numbers: 1100.1492
Study First Received: October 8, 2007
Results First Received: December 17, 2010
Last Updated: May 13, 2014
Health Authority: Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica