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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
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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.
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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 
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
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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
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Time Frame 07-Jun-2006 to 24-Jan-2012.
Additional Description All "Serious Adverse Events (SAEs)" emerging during the TMC125-C217 treatment period are reported below; "Other Adverse Events (not including SAEs)" provided below occurred in at least 0.5% of participants. The duration of the TMC125 treatment period ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.
All Participants Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).

Other Adverse Events
    DUET PLACEBO   DUET TMC125   All Participants
Total, other (not including serious) adverse events       
# participants affected / at risk   160/256 (62.50%)   137/247 (55.47%)   297/503 (59.05%) 
Gastrointestinal disorders       
Diarrhoea * 1       
# participants affected / at risk   32/256 (12.50%)   24/247 (9.72%)   56/503 (11.13%) 
Nausea * 1       
# participants affected / at risk   20/256 (7.81%)   15/247 (6.07%)   35/503 (6.96%) 
General disorders       
Injection site nodule * 1       
# participants affected / at risk   14/256 (5.47%)   8/247 (3.24%)   22/503 (4.37%) 
Pyrexia * 1       
# participants affected / at risk   13/256 (5.08%)   6/247 (2.43%)   19/503 (3.78%) 
Infections and infestations       
Bronchitis * 1       
# participants affected / at risk   18/256 (7.03%)   12/247 (4.86%)   30/503 (5.96%) 
Herpes simplex * 1       
# participants affected / at risk   32/256 (12.50%)   17/247 (6.88%)   49/503 (9.74%) 
Influenza * 1       
# participants affected / at risk   18/256 (7.03%)   18/247 (7.29%)   36/503 (7.16%) 
Nasopharyngitis * 1       
# participants affected / at risk   21/256 (8.20%)   15/247 (6.07%)   36/503 (7.16%) 
Oral candidiasis * 1       
# participants affected / at risk   23/256 (8.98%)   14/247 (5.67%)   37/503 (7.36%) 
Sinusitis * 1       
# participants affected / at risk   19/256 (7.42%)   23/247 (9.31%)   42/503 (8.35%) 
Upper respiratory tract infection * 1       
# participants affected / at risk   14/256 (5.47%)   11/247 (4.45%)   25/503 (4.97%) 
Urinary tract infection * 1       
# participants affected / at risk   14/256 (5.47%)   8/247 (3.24%)   22/503 (4.37%) 
Metabolism and nutrition disorders       
Hypertriglyceridaemia * 1       
# participants affected / at risk   12/256 (4.69%)   15/247 (6.07%)   27/503 (5.37%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1       
# participants affected / at risk   7/256 (2.73%)   14/247 (5.67%)   21/503 (4.17%) 
Nervous system disorders       
Headache * 1       
# participants affected / at risk   18/256 (7.03%)   10/247 (4.05%)   28/503 (5.57%) 
Psychiatric disorders       
Insomnia * 1       
# participants affected / at risk   13/256 (5.08%)   7/247 (2.83%)   20/503 (3.98%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1       
# participants affected / at risk   12/256 (4.69%)   14/247 (5.67%)   26/503 (5.17%) 
Skin and subcutaneous tissue disorders       
Rash * 1       
# participants affected / at risk   24/256 (9.38%)   4/247 (1.62%)   28/503 (5.57%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 9.1



  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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