In the news ... 2006 archive
Expanded Access Program Opens for Etravirine
September 11, 2006
Tibotec Therapeutics has opened an expanded access program (EAP)
for its experimental HIV drug, etravirine (TMC-125). Etravirine
is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which
works against HIV that is resistant to the available drugs from
this class, including Sustiva (efavirenz), Viramune (nevirapine)
and Rescriptor (delaverdine).
In addition to providing early access to etravirine for people
who need it, this program will collect information on safety, side
effects and effectiveness of etravirine when used together along
with other HIV drugs.
People may be eligible for the program if:
- They have taken anti-HIV therapies in each of the three major
classes (NRTIs, NNRTIs, PIs). If you are not sure if you have
taken drugs in each of these classes, see the drug ID chart.
- They have resistance to NNRTIs, despite having never taken these
drugs, can be included if they have taken drugs in PI and NRTI
classes before, and meet all the other inclusion criteria.
- They have taken two different PI-based regimens before.
- They are unable to use currently approved NNRTIs due to resistance
and/or intolerance
- They are currently taking an anti-HIV therapy regimen, though
not achieving adequate suppression of HIV on his/her current regimen.
People may not be eligible for this program if:
- They previously or currently are participating in the “DUET”
studies that study this drug together with the protease inhibitor
Prezista (darunavir, TMC-114).
- They are using therapies that are not allowed to be used together
with etravirine, including anti-HIV drugs.
- They are using experimental anti-HIV therapies (though some
exceptions may be made).
- Have any active significant disease (for example, cardiac dysfunction,
pancreatitis, acute viral infection) or significant findings during
the medical and laboratory screening for the program.
- Have a history of significant health events that are not resolved
or stabilized for at least 30 days before screening for the program.
- They are a pregnant or breast-feeding female.
- They are a woman of childbearing potential not using effective
non-hormonal birth control methods.
- They have specific laboratory abnormalities.
- They have symptoms or laboratory evidence of significantly decreased
liver function.
People interested in this program can get more information at www.clinicaltrials.gov.
