A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
An Open-Label Trial With TMC125 in HIV-1 Infected Subjects, Who Were Randomized to a TMC125 Treatment Arm in a Sponsor-Selected TMC125 Trial and Were Treated for at Least 48 Weeks
2 other identifiers
interventional
211
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2005
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
April 9, 2013
CompletedJune 20, 2013
June 1, 2013
3.2 years
August 8, 2005
February 27, 2013
June 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
Number of participants who reported at least 1 of the adverse events.
Up to 3 years
Secondary Outcomes (9)
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48
Week 48
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96
Week 96
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96
Week 96
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192
Week 192
Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48
Week 48
- +4 more secondary outcomes
Study Arms (1)
Etravirine + 2 antiretrovirals
EXPERIMENTALInterventions
Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available.
Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).
Eligibility Criteria
You may qualify if:
- Participants who were previously randomized to an etravirine (ETR) treatment arm and have completed at least 48 weeks of treatment with ETR
- Participants who will be able to comply with the protocol requirements
- Participants general medical condition should not interfere with the assessments and the completion of the study
You may not qualify if:
- Use of disallowed concomitant therapy unless a prior exemption had been granted
- Participant with any treatment-emergent condition or exacerbation of underlying condition during original Phase II study
- Agrees to protocol-defined use of effective contraception
- Participant with a grade 3 elevation of amylase and/or lipase except for isolated grade 3 increases of amylase with lipase in normal range and no history of pancreatitis
- Participant with any grade 4 toxicity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table; with the exception of grade 4 elevations of triglycerides or glucose asymptomatic or under non-fasting conditions; grade 4 elevation of glucose in participants with pre-existing diabetes
- Participants with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio \[INR\] more than 1.5 or albumin less than 30g/l or bilirubin more than 2.5 x upper limit of normal)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Physician
- Organization
- Tibotec Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals, Ireland Clinical Trial
Tibotec Pharmaceuticals, Ireland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2005
First Posted
August 10, 2005
Study Start
June 1, 2005
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
June 20, 2013
Results First Posted
April 9, 2013
Record last verified: 2013-06