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TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00540449
First received: October 4, 2007
Last updated: October 25, 2012
Last verified: October 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
Human Immunodeficiency Virus Type 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     346     344  
COMPLETED     296 [1]   288 [1]
NOT COMPLETED     50     56  
Adverse Event                 8                 28  
Sponsor's Decision                 2                 1  
Subject Ineligible To Continue The Trial                 1                 2  
Lost to Follow-up                 5                 9  
Subject Non-Compliant                 6                 2  
Subject Reached A Virologic Endpoint                 23                 6  
Withdrawal by Subject                 4                 7  
Other                 1                 1  
[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]
  346     344     690  
Age  
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     343     343     686  
>=65 years     2     1     3  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 9.68     36.7  ± 9.51     36.8  ± 9.59  
Gender  
[units: participants]
     
Female     78     69     147  
Male     268     275     543  
Region Enroll  
[units: participants]
     
Africa     32     31     63  
Asia     47     51     98  
Latin America     60     69     129  
USA, Canada, Europe, Australia     207     193     400  



  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     185/346     248/344  
Gastrointestinal disorders      
Nausea * 1    
# participants affected / at risk     37/346 (10.69%)     33/344 (9.59%)  
Diarrhoea * 1    
# participants affected / at risk     36/346 (10.40%)     53/344 (15.41%)  
General disorders      
Fatigue * 1    
# participants affected / at risk     15/346 (4.34%)     26/344 (7.56%)  
Infections and infestations      
Upper respiratory tract infection * 1    
# participants affected / at risk     33/346 (9.54%)     35/344 (10.17%)  
Nasopharyngitis * 1    
# participants affected / at risk     28/346 (8.09%)     42/344 (12.21%)  
Influenza * 1    
# participants affected / at risk     26/346 (7.51%)     29/344 (8.43%)  
Nervous system disorders      
Headache * 1    
# participants affected / at risk     43/346 (12.43%)     38/344 (11.05%)  
Dizziness * 1    
# participants affected / at risk     26/346 (7.51%)     88/344 (25.58%)  
Somnolence * 1    
# participants affected / at risk     12/346 (3.47%)     23/344 (6.69%)  
Psychiatric disorders      
Abnormal dreams * 1    
# participants affected / at risk     28/346 (8.09%)     41/344 (11.92%)  
Insomnia * 1    
# participants affected / at risk     23/346 (6.65%)     32/344 (9.30%)  
Depression * 1    
# participants affected / at risk     21/346 (6.07%)     15/344 (4.36%)  
Anxiety * 1    
# participants affected / at risk     4/346 (1.16%)     21/344 (6.10%)  
Skin and subcutaneous tissue disorders      
Rash * 1    
# participants affected / at risk     24/346 (6.94%)     41/344 (11.92%)  
* 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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