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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
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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
Participants with human immunodeficiency virus – type 1 (HIV-1) infection were enrolled in this study from DUET Study TMC125-C206 or TMC125-C216 and met the definition of virologic failure at Week 24 or later in these studies, or who completed one of the DUET studies after 96 weeks of treatment.

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.

Participant Flow:   Overall Study
    DUET PLACEBO   DUET TMC125
STARTED   256   247 
COMPLETED   175   195 
NOT COMPLETED   81   52 
Adverse Event                26                8 
Subject Non-Compliant                1                2 
Subject Ineligible To Continue The Trial                1                0 
Subject Reached A Virologic Endpoint                45                32 
Withdrawal by Subject                2                9 
Lost to Follow-up                1                0 
Not specified                4                1 
Pregnancy                1                0 



  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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  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



Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00359021     History of Changes
Other Study ID Numbers: CR002740
TMC125-C217 ( Other Identifier: Tibotec Pharmaceuticals )
TMC125-C206 ( Other Identifier: Tibotec Pharmaceuticals )
TMC125-C216 ( Other Identifier: Tibotec Pharmaceuticals )
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