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
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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.

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

Serious Adverse Events
    TMC278     Efavirenz  
Total, serious adverse events      
# participants affected / at risk     23/346 (6.65%)     31/344 (9.01%)  
Blood and lymphatic system disorders      
Febrile neutropenia * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Cardiac disorders      
Atrial flutter * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Tachycardia * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Congenital, familial and genetic disorders      
Thyroglossal cyst * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Gastrointestinal disorders      
Haematemesis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Peritoneal haemorrhage * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Anal inflammation * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Diarrhoea * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Gastrointestinal haemorrhage * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Nausea * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Vomiting * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
General disorders      
Chest pain * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Adverse drug reaction * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Pelvic mass * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Pyrexia * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Hepatobiliary disorders      
Cholecystitis acute * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Cholelithiasis * 1    
# participants affected / at risk     1/346 (0.29%)     1/344 (0.29%)  
Cholecystitis * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Infections and infestations      
Abscess limb * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Anogenital warts * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Appendicitis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Bacterial infection * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Bronchiectasis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Cellulitis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Diverticulitis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Helicobacter gastritis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Herpes zoster * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Lobar pneumonia * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Neurosyphilis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Pneumonia * 1    
# participants affected / at risk     1/346 (0.29%)     2/344 (0.58%)  
Sepsis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Syphilis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Arthritis bacterial * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Bronchitis * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Cerebral toxoplasmosis * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Gastroenteritis * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Streptococcal bacteraemia * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Tuberculous pleurisy * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Upper respiratory tract infection * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Injury, poisoning and procedural complications      
Alcohol poisoning * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Overdose * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Drug toxicity * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Investigations      
Alanine aminotransferase increased * 1    
# participants affected / at risk     0/346 (0.00%)     2/344 (0.58%)  
Aspartate aminotransferase increased * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Blood alkaline phosphatase increased * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Transaminases increased * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Metabolism and nutrition disorders      
Anorexia * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Musculoskeletal and connective tissue disorders      
Arthralgia * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Joint swelling * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Spondylitis * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Back pain * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Bladder cancer * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Haemangioma * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Kaposi's sarcoma * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Uterine leiomyoma * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Anal cancer stage 0 * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Burkitt's lymphoma * 1    
# participants affected / at risk     0/346 (0.00%)     2/344 (0.58%)  
Nervous system disorders      
Miller fisher syndrome * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Cerebral ischaemia * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Cerebrovascular accident * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Coma * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Headache * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Sciatica * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Psychiatric disorders      
Alcoholism * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Depression * 1    
# participants affected / at risk     1/346 (0.29%)     2/344 (0.58%)  
Drug dependence * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Major depression * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Suicide attempt * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Bipolar disorder * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Homicidal ideation * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Renal and urinary disorders      
Calculus ureteric * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Glomerulonephritis membranous * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Reproductive system and breast disorders      
Cystocele * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Uterovaginal prolapse * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Asthma * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Dyspnoea * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Pneumothorax * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Pulmonary embolism * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Skin and subcutaneous tissue disorders      
Erythema * 1    
# participants affected / at risk     1/346 (0.29%)     0/344 (0.00%)  
Rash generalised * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Surgical and medical procedures      
Bowel preparation * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
Drug rehabilitation * 1    
# participants affected / at risk     0/346 (0.00%)     1/344 (0.29%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 11.0




  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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  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: Tibotec
phone: 1 609 730 7561
e-mail: kboven@its.jnj.com


No publications provided by Tibotec Pharmaceuticals, Ireland

Publications automatically indexed to this study:

Responsible Party: Compound Development Team Leader TMC278, Tibotec Pharmaceutical Limited
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: October 25, 2012
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