At a glance
ClinicalIndex Comparison Record- ✓Previously randomized to etravirine treatment arm in a sponsor-selected Phase II trial
- ✓Completed at least 48 weeks of etravirine treatment
- ✓Able to comply with protocol requirements
- ✓Medical condition does not interfere with study assessments and completion
- ✕Use of disallowed concomitant therapy without prior exemption
- ✕Treatment-emergent condition or exacerbation of underlying condition during original Phase II study
- ✕Grade 3 elevation of amylase and/or lipase (with limited exception for isolated amylase elevation with normal lipase and no pancreatitis history)
- ✕Any grade 4 toxicity per DAIDS grading (exceptions: asymptomatic grade 4 triglycerides/glucose, grade 4 glucose in pre-existing diabetes)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Etravirine (ETR), Nucleotide reverse transcriptase inhibitors (NRTIs), and 2 other interventions for Human Immunodeficiency Virus Type 1. Completed, enrolled 211 participants.
Detailed 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.
Study Details
Timeline
Interventions
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).