GW's Abacavir Enters Open Label Trial

Glaxo Wellcome has initiated an open-label trial of its new-generationnucleoside analog abacavir (1529U89). This study provides patients with long-awaited access to the investigational anti-HIV drug; earlier this year the Marketletter (July 14 issue) reported that AIDS activists and San Francisco officials were to boycott GW's blockbuster antiulcerant Zantac (ranitidine), claiming that the pharmaceutical giant was protecting Retrovir (zidovudine) sales by delaying access to abacavir.

By the end of the year, the study is expected to enroll up to 2,400 AIDS patients in the USA with CD4 cell counts of less than 100mm3 and viral loads greater than 30,000. Based on safety data collected from this trial, as well as other ongoing Phase II and III trials, the trial will be expanded internationally in 1998, according to the company.

GW says that although the drug is being studied in Phase III controlled clinical studies in adults and children, the open label study "has been developed as a way to provide broader access to the compound for patients who have failed other commercially-available treatments and need a new treatment option immediately." AIDS activists estimate that at least 10,000 people have built up resistance to Retrovir.