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TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00665847
First received: April 22, 2008
Last updated: December 27, 2012
Last verified: December 2012
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1
Interventions: Drug: Etravirine (TMC125)
Drug: Optimized background regimen (OBR)

  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
In total, 41 investigators in 13 countries enrolled patients in study TMC125-C213. A total of 103 patients were documented as being enrolled in the study, however 2 patients were randomized in error. Therefore, 101 patients were enrolled and treated with etravirine (ETR) also known as TMC125 and included in the intent-to-treat (ITT) population.

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
TMC125 TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day

Participant Flow:   Overall Study
    TMC125  
STARTED     101  
COMPLETED     76  
NOT COMPLETED     25  
Adverse Event                 8  
Withdrawal by Subject                 2  
Subject non-compliant                 8  
Subject reached a virologic endpoint                 4  
Resistance to TMC125                 1  
Subject ineligible to continue the trial                 1  
Switch to Commercial Medication                 1  



  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
TMC125 TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day

Baseline Measures
    TMC125  
Number of Participants  
[units: participants]
  101  
Age  
[units: years]
Mean ± Standard Deviation
  12.2  ± 2.99  
Gender  
[units: participants]
 
Female     64  
Male     37  
Age Customized  
[units: participants]
 
>=6 to <12 years     41  
>=12 to <18 years     60  



  Outcome Measures
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1.  Primary:   The Number of Patients With Treatment-emergent Adverse Events (TEAEs)   [ Time Frame: 48 weeks ]

2.  Primary:   The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs)   [ Time Frame: 48 weeks ]

3.  Secondary:   Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h)   [ Time Frame: Weeks 4-48 ]

4.  Secondary:   Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h)   [ Time Frame: Week 48 ]

5.  Secondary:   Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax)   [ Time Frame: Week 4 ]

6.  Secondary:   Percentage of Patients With Virologic Response at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:   Change From Baseline in Human Immunodeficiency Virus – Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time   [ Time Frame: Baseline, Week 48 ]

8.  Secondary:   The Change From Baseline in CD4 Cell Counts Over Time   [ Time Frame: Baseline, Week 48 ]

9.  Secondary:   The Emergence of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations (NNRTI RAMs) in Patients Classified as Virologic Failures   [ Time Frame: Baseline and Endpoint (up to 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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