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 (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00540449
First received: October 4, 2007
Last updated: May 29, 2015
Last verified: May 2015
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
One hundred and twelve sites in 21 countries randomized participants. In total, 694 participants were randomized: four participants did not start treatment and 690 participants started treatment (346 in the TMC278 group and 344 in the efavirenz [control ] group).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
TMC278 25 milligram (mg) tablet once daily for 96 weeks.
Efavirenz 600 mg once daily for 96 weeks.

Participant Flow:   Overall Study
    TMC278     Efavirenz  
STARTED     346     344  
COMPLETED     262     266  
NOT COMPLETED     84     78  
Adverse Event                 12                 32  
Sponsor's Decision                 1                 1  
Subject Ineligible To Continue The Trial                 2                 1  
Lost to Follow-up                 19                 17  
Subject Non-Compliant                 7                 5  
Subject Reached A Virologic Endpoint                 32                 8  
Withdrawal by Subject                 10                 10  
Not specified                 1                 4  



  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.
The analysis population included intent to treat (ITT) population defined as all randomized participants who received at least one dose of the study medication.

Reporting Groups
  Description
TMC278 25 milligram (mg) tablet once daily for 96 weeks.
Efavirenz 600 mg 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:   Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/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/ml) at Week 96   [ Time Frame: Week 96 ]

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

5.  Secondary:   Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Post-Week 96 Visit.   [ Time Frame: Variable, ranging from 3 months up to maximum 15 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/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/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: Week 48, Week 96 ]

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame Up to a maximum of 160 weeks for participants in the TMC278 treatment group and up to 147 weeks for participants in the efavirenz treatment group.
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 milligram (mg) tablet once daily for 96 weeks.
Efavirenz 600 mg once daily for 96 weeks.

Other Adverse Events
    TMC278     Efavirenz  
Total, other (not including serious) adverse events      
# participants affected / at risk     231/346 (66.76%)     268/344 (77.91%)  
Gastrointestinal disorders      
Nausea * 1    
# participants affected / at risk     44/346 (12.72%)     38/344 (11.05%)  
Diarrhoea * 1    
# participants affected / at risk     51/346 (14.74%)     61/344 (17.73%)  
Vomiting * 1    
# participants affected / at risk     15/346 (4.34%)     21/344 (6.10%)  
General disorders      
Fatigue * 1    
# participants affected / at risk     20/346 (5.78%)     31/344 (9.01%)  
Infections and infestations      
Upper respiratory tract infection * 1    
# participants affected / at risk     53/346 (15.32%)     51/344 (14.83%)  
Nasopharyngitis * 1    
# participants affected / at risk     45/346 (13.01%)     44/344 (12.79%)  
Influenza * 1    
# participants affected / at risk     37/346 (10.69%)     34/344 (9.88%)  
Syphilis * 1    
# participants affected / at risk     22/346 (6.36%)     15/344 (4.36%)  
Musculoskeletal and connective tissue disorders      
Arthralgia * 1    
# participants affected / at risk     15/346 (4.34%)     20/344 (5.81%)  
Back pain * 1    
# participants affected / at risk     23/346 (6.65%)     24/344 (6.98%)  
Nervous system disorders      
Headache * 1    
# participants affected / at risk     50/346 (14.45%)     44/344 (12.79%)  
Dizziness * 1    
# participants affected / at risk     28/346 (8.09%)     91/344 (26.45%)  
Somnolence * 1    
# participants affected / at risk     14/346 (4.05%)     24/344 (6.98%)  
Psychiatric disorders      
Abnormal dreams * 1    
# participants affected / at risk     29/346 (8.38%)     41/344 (11.92%)  
Insomnia * 1    
# participants affected / at risk     36/346 (10.40%)     39/344 (11.34%)  
Depression * 1    
# participants affected / at risk     25/346 (7.23%)     21/344 (6.10%)  
Anxiety * 1    
# participants affected / at risk     9/346 (2.60%)     27/344 (7.85%)  
Respiratory, thoracic and mediastinal disorders      
Cough * 1    
# participants affected / at risk     23/346 (6.65%)     20/344 (5.81%)  
Skin and subcutaneous tissue disorders      
Rash * 1    
# participants affected / at risk     26/346 (7.51%)     42/344 (12.21%)  
Pruritus * 1    
# participants affected / at risk     8/346 (2.31%)     18/344 (5.23%)  
Vascular disorders      
Hypertension * 1    
# participants affected / at risk     21/346 (6.07%)     18/344 (5.23%)  
* 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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  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.


Results Point of Contact:  
Name/Title: Medical Leader
Organization: Janssen Infectious Diseases BVBA
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided by Tibotec Pharmaceuticals, Ireland

Publications automatically indexed to this study:

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00540449     History of Changes
Obsolete Identifiers: NCT00613639
Other Study ID Numbers: CR002689, TMC278-TIDP6-C209
Study First Received: October 4, 2007
Results First Received: June 14, 2011
Last Updated: May 29, 2015
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority
Canada: Health Canada
Great Britain: Medicines and Healthcare Products Regulatory Agency
Taiwan: Department of Health
Great Britain: Research Ethics Committee