Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc. - Wednesday, 6 August 1997, 10:44 AM EDT
A Glaxo spokeswoman said the drug is being tested in a so-called open-label trial, whereby all patients know they will be administered the drug and not a placebo.
The opposite of an open-label trial is standard clinical trial, or "double-blind," testing, when patients don't know whether they take the real drug or not.
Glaxo said the 1592 drug, which is being tested in Phase III controlled clinical studies, is a nucleoside analogue reverse transcriptase inhibitor. It added preliminary data from early clinical trials suggested the drug may have potent antiviral activity.
The company said the new open-label trial gives patients for whom other commercially available treatment has failed a new treatment option immediately. It added it hopes the study will generate data about the drug's possible use for patients with advanced HIV disease.
Glaxo said it will enroll about 100 patients per week in the open-label trials.
The company said patients must have CD4 cell counts of less than 100/mm3 and viral loads greater than 30,000 on a currently acceptable combination regimen to qualify for the trial. Patients also must have been treated with two nucleoside analogues and a protease inhibitor or must be without treatment due to intolerance to prior combination therapy, it added.
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