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Study TMC114-C226: TMC114 Expanded Access Program (EAP), Co-enrollment in MK-0518 Phase III studies
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Tibotec BVBA
Gen De Wittelaan L 11B 3
2800 Mechelen Belgium
Tel +32 15 293 100
Fax +32 15 286 347
www.tibotec.com
February 27, 2006
Dear Investigator:
Following review of available data on investigational drugs TMC114 and MK-0518 with our colleagues at Merck Research Laboratories, an agreement has been reached to allow co-enrollment of patients in the ongoing TMC114-C226 EAP and in the MK-0518 Phase III studies.
The TMC114-226 EAP protocol states that investigational antiretrovirals (ARVs) may be allowed when favorable pharmacokinetic interaction and safety data support co-administration with TMC114 and low-dose RTV. It is expected that MK-0518 will have limited interactions with drugs that are primarily metabolized through the CYP 3A system, such as TMC114. Further information is provided in the MK-0518 Investigator Brochure.
Please review the following instructions on how to best proceed with co-enrollment.
Please do not hesitate to contact us if you have any questions.
Sincerely,
Eric Lefebvre, MD
Director Global Clinical Development, TMC114
Tibotec
Elefebvr@tibus.jnj.com
1 609 730 7504
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