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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 (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00543725
First received: October 11, 2007
Last updated: March 3, 2016
Last verified: March 2016
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


  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
Efavirenz 600 mg once daily
Total Total of all reporting groups

Baseline Measures
   TMC278   Efavirenz   Total 
Overall Participants Analyzed 
[Units: Participants]
 340   338   678 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   339   337   676 
>=65 years   1   1   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.7  (9.39)   36.4  (8.92)   36.5  (9.15) 
Gender 
[Units: Participants]
     
Female   90   94   184 
Male   250   244   494 
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:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48   [ Time Frame: Week 48 ]

3.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96   [ Time Frame: Week 96 ]

4.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96   [ Time Frame: Week 96 ]

5.  Secondary:   Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).   [ Time Frame: Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz ]

6.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48   [ Time Frame: Week 48 ]

7.  Secondary:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96   [ Time Frame: Week 96 ]

8.  Secondary:   Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)   [ Time Frame: Baseline, Week 48, and Week 96 ]

9.  Secondary:   Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure   [ Time Frame: Week 96 ]


  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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