A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00128830
First received: August 8, 2005
Last updated: June 10, 2013
Last verified: June 2013
Results First Received: February 27, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus Type 1
Interventions: Drug: Etravirine (ETR)
Drug: Nucleotide reverse transcriptase inhibitors (NRTIs)
Drug: Protease inhibitors (PIs)
Drug: Enfuvirtide (ENF)

  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 this study, 211 participants were enrolled in 12 different countries. The majority of participants (49%) were enrolled in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 211 participants (93 who rolled over from the etravirine arm of study TMC125-C203 (NCT00412646), 85 who rolled over from the etravirine arm of study TMC125-C223 (NCT00081978), 29 who rolled over from study TMC125-C211 (NCT00111280) and 4 who rolled over from study TMC125-C209) received treatment with etravirine.

Reporting Groups
  Description
Etravirine 800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)

Participant Flow:   Overall Study
    Etravirine  
STARTED     211  
COMPLETED     139  
NOT COMPLETED     72  
Adverse Event                 10  
Withdrawal by Subject                 14  
Lost to Follow-up                 4  
Reached a virologic endpoint                 29  
Non-compliant                 4  
Discontinued or ineligible for study                 2  
Unspecified                 9  



  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
Etravirine 800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)

Baseline Measures
    Etravirine  
Number of Participants  
[units: participants]
  211  
Age  
[units: years]
Median ( Full Range )
  46.0  
  ( 32 to 70 )  
Gender  
[units: participants]
 
Female     21  
Male     190  
Race/Ethnicity, Customized  
[units: Participants]
 
Asian     1  
Black or African American     24  
White     164  
Hispanic     16  
Other     6  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Up to 3 years ]

2.  Secondary:   Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48   [ Time Frame: Week 48 ]

3.  Secondary:   Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96   [ Time Frame: Week 96 ]

4.  Secondary:   Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96   [ Time Frame: Week 96 ]

5.  Secondary:   Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192   [ Time Frame: Week 192 ]

6.  Secondary:   Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48   [ Time Frame: Week 48 ]

7.  Secondary:   Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96   [ Time Frame: Week 96 ]

8.  Secondary:   Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96   [ Time Frame: Week 96 ]

9.  Secondary:   Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192   [ Time Frame: Week 192 ]

10.  Secondary:   Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)   [ Time Frame: Baseline and Endpoint (ie, the last available time point during the treatment period) ]


  Serious Adverse Events


  Other Adverse Events


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


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.  


Results Point of Contact:  
Name/Title: Trial Physician
Organization: Tibotec Pharmaceuticals
phone: +32-14-607-767


No publications provided


Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00128830     History of Changes
Obsolete Identifiers: NCT00980772
Other Study ID Numbers: CR002731, TMC125-C229
Study First Received: August 8, 2005
Results First Received: February 27, 2013
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority