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


  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]
  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


  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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