3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

NO SIGNIFICANT INTERACTION BETWEEN TMC125 AND DIDANOSINE (DDI) IN HEALTHY VOLUNTEERS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePe3.3C16

Scholler M., Hoetelmans R., Bollen S., Vandermeulen K., Peeters M., Bastiaanse L., Debroye C., Woodfall B.
Tibotec, Mechelen, Belgium

INTRODUCTION: TMC125 is a novel NNRTI with potent in vitro activity against both wild-type HIV and viruses resistant to currently approved NNRTIs. TMC125 is being investigated in Phase IIb dose-finding trials. A study was conducted to evaluate the pharmacokinetic interaction between TMC125 and ddI.

METHODS: TMC125-C157 was an open-label, one-sequence, cross-over, randomized trial in 16 healthy subjects to investigate the pharmacokinetic interaction between TMC125 and ddI at steady-state. In Session I, 800 mg TMC125 b.i.d. was administered for 7 days followed by a single morning dose on day 8. After a washout period of at least 14 days, Session II consisted of a repeated-dose regimen of ddI (Videx EC) 400 mg q.d. from day 1 – 16. TMC125 800 mg b.i.d. was co-administered from day 9 – 16 in 8 subjects randomized to Group 1 and from day 1 – 8 in 8 subjects randomized to Group 2. TMC125 was administered with food and ddI was administered 2 hours before TMC125 intake. The pharmacokinetics of TMC125 and ddI were assessed over 12 and 24 hours, respectively.

RESULTS: 14 subjects completed the study. When combined with ddI, TMC125 AUC_12h was 111% (90% CI 98 – 124%) compared to administration of TMC125 alone. TMC125 C_max and C_min were 116% (90% CI 102 – 132%) and 104% (90% CI 93 – 117%), respectively. AUC_24h and C_max of ddI were 99% (90% CI 79 – 125%) and 91% (90% CI 58 – 142%), respectively, when combined with TMC125 compared to administration of ddI alone. TMC125 and ddI were generally safe and well tolerated.

CONCLUSIONS: No clinically relevant interaction was observed between TMC125 800 mg b.i.d. and ddI 400 mg q.d. in healthy volunteers. The combination of TMC125 and ddI was generally safe and well tolerated. No dose adjustments are necessary when TMC125 and ddI are combined.

Download PDF of this abstract.

050724
Clinical | WePe3.3C16 | Monika Scholler
Drug Interactions

Copyright © 2005 - International AIDS Society (IAS). All information and content relating to the abstracts from the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, such as text, graphics, logos, button icons, images, audio clips, and software is protected by copyright. Permission is hereby granted for the non-commercial use or reproduction of the information on this web site, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.

AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2005. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. Permission is hereby granted for the non-commercial use or reproduction of the information herein, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.