|
Who can participate in the TMC125 EAP
The EAP is available to HIV-1 affected adults who:
- are 18 years of age or older
- have limited or no treatment options due to virological failure or intolerance to multiple ARV regimes
- are unable to use currently approved NNRTIs due to resistance and or intolerance
- have received licenced oral treatment from each of the 3 major classes of HIV drugs (N(t)RTI, NNRTIs, PIs)
- Note for PIs : received 1 PI-based regimen*
- Note for NNRTI: primary NNRTI resistance can be included if experienced with at least 2 classes of ARVs (PIs, N(t)RTIs) and meet all the other inclusion criteria
* please note: country specific criteria may apply
The expanded access program is currently available in these countries: Austria, Hong Kong, Korea, Mexico, New Zealand, Portugal, Russia, Taiwan and Turkey.
TMC125 received conditional marketing authorization from the European Commission on 28 August 2008. Following local regulations and/or local reimbursement discussions, the EAP has been closed for new enrollment in the following countries: Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, The Netherlands, Norway, Romania, Slovenia, Spain and Sweden.
TMC125 has also received approval in the following non EU Countries that participated in the EAP. Following local regulations and/or local reimbursement discussions, the EAP has been closed for new enrollment in the following countries: Australia,
Canada,
Colombia, Israel, Switzerland
.
Patients in these countries who are already enrolled in the EAP may be continued until further notification by the sponsor representative.
For more information on TMC125, please contact your treating physician (for patients) or your local Janssen-Cilag affiliate (for healthcare professionals).
Please continue to check this site for EAP updates.
How to apply for participation
For patients:
As a patient please discuss participation with your health care professional. If the expanded access program is available in your country your health care professional can register as an EAP participating site and obtain the investigational medication.
For health care professionals:
If you are a healthcare professional and are interested in participating in the TMC125 EAP, you can apply for registration here: Principal Investigator.
Your application will be reviewed by a Representative of the Sponsor, and you will be informed of your eligibility to participate in the EAP program. The required information to participate includes the contact details of the PI as well as the address to which the investigational medication is to be delivered. Upon acceptance of your registration, and validation of the entered details, the site will be contacted by a Representative of the Sponsor and will be informed of the next steps.
For sites intending to use the Electronic Data Capture (EDC) System, registration of other Site Personnel involved in EDC is required following registration of the Principal Investigator. Other Site Personnel can register here: Site Personnel.
Additional information
All health care professionals and people living with HIV/aids may obtain information by emailing: tibbe-info@its.jnj.com or visiting: http://www.clinicaltrials.gov (an FDA website with an overview of all clinical trials).
|
