TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00543725
First received: October 11, 2007
Last updated: May 14, 2012
Last verified: May 2012
Results First Received: June 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
HIV-1
Interventions: Drug: TMC278
Drug: efavirenz

  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
TMC278 25 mg tablet once daily for 96 weeks
Efavirenz 600mg once daily for 96 weeks

Participant Flow:   Overall Study
    TMC278     Efavirenz  
STARTED     340     338  
COMPLETED     296 [1]   282 [1]
NOT COMPLETED     44     56  
Adverse Event                 15                 25  
Protocol Violation                 0                 1  
Subject Ineligible To Continue The Trial                 1                 0  
Lost to Follow-up                 10                 6  
Subject Non-Compliant                 2                 2  
Subject Reached A Virologic Endpoint                 13                 8  
Withdrawal by Subject                 2                 11  
Other                 1                 3  
[1] 'Completed' represents the subjects that are ongoing at the time of cut-off for the WK48 analysis



  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.
No text entered.

Reporting Groups
  Description
TMC278 25 mg tablet once daily for 96 weeks
Efavirenz 600mg once daily for 96 weeks
Total Total of all reporting groups

Baseline Measures
    TMC278     Efavirenz     Total  
Number of Participants  
[units: participants]
  340     338     678  
Age  
[units: years]
Mean ± Standard Deviation
  36.3  ± 9.23     36.3  ± 9.03     36.3  ± 9.13  
Gender  
[units: participants]
     
Female     90     94     184  
Male     250     244     494  
AgeCategoricalOther  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     310     309     619  
>= 65 years     0     1     1  
Region Enroll  
[units: participants]
     
Africa     19     38     57  
Asia     59     61     120  
Latin America     90     85     175  
USA, Canada, Europe, Australia     172     154     326  



  Outcome Measures
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1.  Primary:   Virological Response[ITT - TLOVR,<50 Copies/mL]   [ Time Frame: Week 48 ]

2.  Secondary:   Virological Response[ITT - Snapshot,<50 Copies/mL]   [ Time Frame: Week 48 ]
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Measure Type Secondary
Measure Title Virological Response[ITT - Snapshot,<50 Copies/mL]
Measure Description The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/mL (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/mL in the Wk48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/mL, and subjects who had a switch in background regimen that was not permitted by the protocol.
Time Frame Week 48  
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.
The ITT analysis set was considered the primary efficacy analysis set.

Reporting Groups
  Description
TMC278 25 mg tablet once daily for 96 weeks
Efavirenz 600mg once daily for 96 weeks

Measured Values
    TMC278     Efavirenz  
Number of Participants Analyzed  
[units: participants]
  340     338  
Virological Response[ITT - Snapshot,<50 Copies/mL]  
[units: Participants]
   
Virologic Response HIV RNA <50 copies/mL at Wk 48     281     265  
Virologic Failure     41     38  
No Viral Load Data in 48 week window     18     35  


Statistical Analysis 1 for Virological Response[ITT - Snapshot,<50 Copies/mL]
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Regression, Logistic
P Value [4] <.0001
Difference in proportion of response [5] 3.9
95% Confidence Interval ( -1.9 to 9.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Difference in proportion responders was estimated through the logistic regression model.




  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Leader
Organization: Tibotec
phone: 1 609 730 7561
e-mail: kboven@its.jnj.com


No publications provided by Tibotec Pharmaceuticals, Ireland

Publications automatically indexed to this study:

Responsible Party: Compound Development Team Leader TMC278, Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT00543725     History of Changes
Obsolete Identifiers: NCT00614692
Other Study ID Numbers: CR002704, TMC278-TIDP6-C215
Study First Received: October 11, 2007
Results First Received: June 14, 2011
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority
Canada: Health Canada
China: Food and Drug Administration
Great Britain: Medicines and Healthcare Products Regulatory Agency
United States: Federal Government