eConsent - chances and challenges for a multi-stakeholder community

The consent document is not only the input but also the output and final agreement between participant and investigator. The ability to store and retrieve the document (e.g. by printing, downloading) is a "must have" digital feature of each eConsent tool. eConsent tools should be simple, self-explanatory, and easy-to-use. If they multiply investigator’s workload or frustrate participants, it will not work. But there is no "one size fits all" eConsent model. Each disease, each study, each site, each participant might have different needs. Clearly the COVID-19 pandemic increased the awareness and openness for eConsent, but it also showed that the impact of in-person contacts should not be underestimated. Different aspects should be considered when selecting the eConsent digital features for a disease, study, sites and participants. Ultimately, eConsent tools should be flexible and become as easy to use and create as a paper consent. In this webinar, Hilde Vanaken will speak about eConsent terminologies, requirements, advantages, and hurdles, and share some insights in the harmonization activities ongoing in the multistakeholder EFGCP initiative

HIV RNA suppression rates after 24 weeks of treatment with etravirine, darunavir/ritonavir and raltegravir in the etravirine early access programme

SCOPUS: le.jinfo:eu-repo/semantics/publishe

Antiretroviral treatment use and HIV RNA suppression rates for 877 European patients in the etravirine expanded access programme

info:eu-repo/semantics/nonPublishe

Pharmacokinetic and pharmacodynamic study of the concomitant administration of methadone and TMC125 in HIV-negative volunteers

TMC125 is a nonnucleoside reverse transcriptase inhibitor (NNRTI) with potent in vitro activity against wild-type and NNRTI-resistant HIV-1. TMC125 is an inducer of CYP3A and an inhibitor of CYP2C. This trial evaluated the effect of TMC125 on the pharmacokinetics and pharmacodynamics of methadone. In an open-label, add-on, 1-way interaction trial, 16 male HIV-negative volunteers on stable methadone maintenance therapy received 100 mg TMC125 bid for 14 days. Plasma concentrations and pharmacokinetic parameters of R- and S-methadone isomers were determined on days -1, 7, and 14 and of TMC125 on days 7 and 14. Safety and tolerability were assessed. The LSmeans ratios (90% confidence interval) for AUC(24h), C(max), and C(min) of the pharmacologically active R-methadone were 1.08 (1.02-1.13), 1.03 (0.97-1.09), and 1.12 (1.05-1.19), respectively, on day 7 and 1.06 (0.99-1.13), 1.02 (0.96-1.09), and 1.10 (1.02-1.19), respectively, on day 14 compared with methadone alone. No withdrawal symptoms were observed; dose adjustment of methadone was not required. The concomitant administration of TMC125 and methadone was generally safe and well tolerated. TMC125 has no clinically relevant effect on the pharmacokinetics or pharmacodynamics of methadone. No dose adjustment for methadone is anticipated when coadministered with TMC12