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An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00359021
First received: July 28, 2006
Last updated: May 6, 2014
Last verified: May 2014
Results First Received: January 29, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1
Intervention: Drug: TMC125

  Participant Flow


  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
DUET PLACEBO Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
DUET TMC125 Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
Total Total of all reporting groups

Baseline Measures
    DUET PLACEBO     DUET TMC125     Total  
Number of Participants  
[units: participants]
  256     247     503  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     252     245     497  
>=65 years     4     2     6  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 8.28     46.6  ± 7.01     46.7  ± 7.68  
Gender  
[units: participants]
     
Female     27     37     64  
Male     229     210     439  



  Outcome Measures
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1.  Primary:   The Number of Participants Experiencing Adverse Events   [ Time Frame: 1 week to 180 weeks, with a median of 62 weeks ]

2.  Secondary:   The Percentage of Participants With Virologic Outcomes Over Time   [ Time Frame: Weeks 24, 48, and 96 ]

3.  Secondary:   Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)   [ Time Frame: Baseline, Week 24, Week 48, and Week 96 ]


  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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  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: SENIOR DIRECTOR R&D
Organization: Tibotec
phone: 1 609 730-7548


No publications provided


Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00359021     History of Changes
Other Study ID Numbers: CR002740, TMC125-C217, TMC125-C206, TMC125-C216
Study First Received: July 28, 2006
Results First Received: January 29, 2013
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority