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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:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00543725
First received: October 11, 2007
Last updated: May 14, 2012
Last verified: May 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
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     340     338  
COMPLETED     296 [1]   282 [1]
NOT COMPLETED     44     56  
Adverse Event                 15                 25  
Protocol Violation                 0                 1  
Subject Ineligible To Continue The Trial                 1                 0  
Lost to Follow-up                 10                 6  
Subject Non-Compliant                 2                 2  
Subject Reached A Virologic Endpoint                 13                 8  
Withdrawal by Subject                 2                 11  
Other                 1                 3  
[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]
  340     338     678  
Age  
[units: years]
Mean ± Standard Deviation
  36.3  ± 9.23     36.3  ± 9.03     36.3  ± 9.13  
Gender  
[units: participants]
     
Female     90     94     184  
Male     250     244     494  
AgeCategoricalOther  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     310     309     619  
>= 65 years     0     1     1  
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:   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     22/340 (6.47%)     24/338 (7.10%)  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     1/340 (0.29%)     1/338 (0.30%)  
Thrombocytopenia * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Pancytopenia * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Gastrointestinal disorders      
Diarrhoea * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Inguinal hernia * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Intestinal obstruction * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Jejunitis * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Vomiting * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Abdominal pain * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Pancreatitis * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
General disorders      
Asthenia * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Non-cardiac chest pain * 1    
# participants affected / at risk     1/340 (0.29%)     1/338 (0.30%)  
Hepatobiliary disorders      
Cholecystitis acute * 1    
# participants affected / at risk     2/340 (0.59%)     0/338 (0.00%)  
Cholelithiasis * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Hyperbilirubinaemia * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Immune system disorders      
Allergy to arthropod sting * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Drug hypersensitivity * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Food allergy * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Infections and infestations      
Pneumonia * 1    
# participants affected / at risk     2/340 (0.59%)     0/338 (0.00%)  
Bronchitis * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Bronchopneumonia * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Furuncle * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Gastroenteritis viral * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Helicobacter gastritis * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Isosporiasis * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Pulmonary tuberculosis * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Cerebral toxoplasmosis * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Cyclosporidium infection * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Dysentery * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Encephalitis herpes * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Hepatitis c * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Herpes zoster * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Meningitis bacterial * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Pelvic inflammatory disease * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Respiratory tract infection * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Staphylococcal infection * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Injury, poisoning and procedural complications      
Clavicle fracture * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Fall * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Humerus fracture * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Pelvic fracture * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Brain contusion * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Lumbar vertebral fracture * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Radius fracture * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Investigations      
Brain scan abnormal * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Blood amylase increased * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Lipase increased * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Metabolism and nutrition disorders      
Dehydration * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Uterine leiomyoma * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Nervous system disorders      
Cerebellar infarction * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Convulsion * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Dizziness * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Cerebrovascular accident * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Grand mal convulsion * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Haemorrhage intracranial * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Pregnancy, puerperium and perinatal conditions      
Pregnancy * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Psychiatric disorders      
Depression * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Sleep disorder * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Suicide attempt * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Acute psychosis * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Alcohol withdrawal syndrome * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Psychotic disorder due to a general medical condition * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Renal and urinary disorders      
Renal failure acute * 1    
# participants affected / at risk     1/340 (0.29%)     1/338 (0.30%)  
Respiratory, thoracic and mediastinal disorders      
Pneumothorax * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Asthma * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Respiratory failure * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Skin and subcutaneous tissue disorders      
Pruritus generalised * 1    
# participants affected / at risk     1/340 (0.29%)     0/338 (0.00%)  
Palmar-plantar erythrodysaesthesia syndrome * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
Rash * 1    
# participants affected / at risk     0/340 (0.00%)     1/338 (0.30%)  
* 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: NCT00543725     History of Changes
Obsolete Identifiers: NCT00614692
Other Study ID Numbers: CR002704, TMC278-TIDP6-C215
Study First Received: October 11, 2007
Results First Received: June 14, 2011
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority
Canada: Health Canada
China: Food and Drug Administration
Great Britain: Medicines and Healthcare Products Regulatory Agency
United States: Federal Government