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
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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.
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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 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    TMC278     Efavirenz  
Total, other (not including serious) adverse events      
# participants affected / at risk     225/340     241/338  
Gastrointestinal disorders      
Nausea * 1    
# participants affected / at risk     55/340 (16.18%)     64/338 (18.93%)  
Diarrhoea * 1    
# participants affected / at risk     42/340 (12.35%)     41/338 (12.13%)  
Vomiting * 1    
# participants affected / at risk     19/340 (5.59%)     23/338 (6.80%)  
General disorders      
Fatigue * 1    
# participants affected / at risk     16/340 (4.71%)     27/338 (7.99%)  
Infections and infestations      
Nasopharyngitis * 1    
# participants affected / at risk     41/340 (12.06%)     33/338 (9.76%)  
Upper respiratory tract infection * 1    
# participants affected / at risk     28/340 (8.24%)     31/338 (9.17%)  
Bronchitis * 1    
# participants affected / at risk     21/340 (6.18%)     5/338 (1.48%)  
Influenza * 1    
# participants affected / at risk     21/340 (6.18%)     25/338 (7.40%)  
Pharyngitis * 1    
# participants affected / at risk     18/340 (5.29%)     7/338 (2.07%)  
Musculoskeletal and connective tissue disorders      
Back pain * 1    
# participants affected / at risk     14/340 (4.12%)     21/338 (6.21%)  
Nervous system disorders      
Headache * 1    
# participants affected / at risk     52/340 (15.29%)     54/338 (15.98%)  
Dizziness * 1    
# participants affected / at risk     41/340 (12.06%)     106/338 (31.36%)  
Somnolence * 1    
# participants affected / at risk     16/340 (4.71%)     28/338 (8.28%)  
Psychiatric disorders      
Insomnia * 1    
# participants affected / at risk     31/340 (9.12%)     20/338 (5.92%)  
Abnormal dreams * 1    
# participants affected / at risk     18/340 (5.29%)     25/338 (7.40%)  
Depression * 1    
# participants affected / at risk     17/340 (5.00%)     15/338 (4.44%)  
Respiratory, thoracic and mediastinal disorders      
Cough * 1    
# participants affected / at risk     26/340 (7.65%)     10/338 (2.96%)  
Skin and subcutaneous tissue disorders      
Rash * 1    
# participants affected / at risk     12/340 (3.53%)     48/338 (14.20%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 11.0



  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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