We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00665847
First Posted: April 24, 2008
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
Results First Submitted: June 14, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV-1
Interventions: Drug: Etravirine (TMC125)
Drug: Optimized background regimen (OBR)

  Participant Flow
  Hide Participant Flow

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
No text entered.

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


  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director
Organization: Tibotec Pharmaceuticals, Ireland
phone: 32 14 641 265
e-mail: gdsmedt1@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00665847     History of Changes
Obsolete Identifiers: NCT00750542
Other Study ID Numbers: CR002746
TMC125-TiDP35-C213 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
2007-007086-21 ( EudraCT Number )
First Submitted: April 22, 2008
First Posted: April 24, 2008
Results First Submitted: June 14, 2012
Results First Posted: December 21, 2012
Last Update Posted: April 23, 2015