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Boehringer Ingelheim launches new HIV/ Aids trial
Boehringer Ingelheim has confirmed the launch of a new HIV/Aids trial which will compare the efficacy and safety of a new extended release, one-pill, once-daily formulation of Viramune (neviripine) with the currently approved twice-daily Viramune.
The VERXVE study will see over 1,000 patients enrolled from across 18 countries in Europe, North America, South America, South Africa and Australia.
Dr Keikawus Arasteh, director of the department of infectious diseases and gastroenterology at the Auguste Victoria Hospital in Berlin, highlighted that the current twice-daily dose was already proven to be an “effective, tolerable, and durable treatment option”.
However, he indicated: “The VERXVE study is an important trial as it is in the patients’ interest to reduce the pill burden in HIV/Aids as much as possible and we expect that the efficacy and safety will be the same in this simplified treatment regimen.”
The trial’s primary endpoint will be virologic response and whether the suppression of virus load to < 50 copies/ml is seen after 48 weeks. Last month, Boehringer Ingelheim announced that the Committee for Medicinal Products in Human Use of the European Medicines Agency had issued a positive recommendation to give marketing authorisation to Pradaxa (dabigatran etexilate).
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