Description:

ODM derived from http://clinicaltrials.gov/show/NCT00354627

Link:

http://clinicaltrials.gov/show/NCT00354627

Keywords:
Versions (2) ▾
  1. 3/13/12
  2. 4/14/14
Uploaded on:

April 14, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00354627 HIV-1

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
Patient has previously received 2 different PI-based regimens
Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
Exclusion Criteria
Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
Use of investigational ARVs (with exceptions)
Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
Pregnant or breast-feeding female
Female patient of childbearing potential not using effective non-hormonal birth control methods
Patients with specific laboratory abnormalities
Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.