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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).

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ClinicalTrials.gov Identifier: NCT00359021
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : March 7, 2013
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV-1
Intervention: Drug: TMC125

  Participant Flow

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
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
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

  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

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