The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs.

This is an open label trial with primary objective to provide early access to TMC125 for
treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV)
regimens and have limited treatment options with currently approved ARVs. The secondary
objective of this trial is to gather information on the safety and tolerability aspects of
TMC125 in combination with other ARVs. Available efficacy data will also be collected.
Patients should be at least 3-class experienced or 2-class experienced with primary
non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. They should also have
previously received 2 different protease inhibitor-based regimens (low-dose ritonavir is not
counted as a protease inhibitor (PI) regimen), be on a treatment interruption or not be
virologically suppressed on their current regimen, and not be able to use currently approved
NNRTIs due to resistance (primary or acquired) and/or intolerance. Patients must also meet
all in- and exclusion criteria. TMC125 (200mg twice daily) will be provided once the patient
has been confirmed eligible for entry. Once treatment with TMC125 in combination with other
ARVs has been initiated, patients must be instructed to follow the recommended visit
schedule based on routine clinical care. Safety and tolerability of the entire
antiretroviral therapy (ART) regimen, including TMC125, should be monitored by the
investigator as per standard clinical practice. However, it is recommended that visits be
planned 4 and 12 weeks following initiation of TMC125 in combination with other ARVs and
every 12 weeks thereafter while on therapy during this trial. Adverse events (AEs) leading
to treatment interruption or discontinuation and all serious adverse events (SAEs), with the
exception of Acquired Immunodeficiency Syndrome (AIDS) defining illnesses (CDC class C)
unless fatal or considered to be related to TMC125, will be collected. Other adverse events
will be collected only if required as per local regulations. The background ARVs may be
changed at any time during the trial, at the discretion of the investigator due to the
development of resistance, intolerance, toxicity, etc. while continuing treatment with
TMC125 if in the investigator's assessment the patient still benefits from treatment with
TMC125. If changes in the background regimen are made, it is recommended that a follow-up
visit be planned 4 weeks after the change in therapy. Treatment with investigational
medication will be continued until virologic failure, treatment-limiting toxicity, subject
lost to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC125 development or
when TMC125 has become commercially available in the patient's country. Patients will be
instructed to orally take two 100 mg tablets of TMC125 following a meal every 12 hours.
TMC125 (200 mg twice daily) must be used in combination with other antiretroviral drugs.
Treatment with investigational medication will continue until virologic failure,
treatment-limiting toxicity, patient lost to follow-up, withdrawal, pregnancy,
discontinuation of TMC125 development or when TMC125 becomes commercially available in the
patient's country.