Anyone interested in participating should bear in mind that Glaxo has not yet made a provision for individuals to continue receiving 1592 after completing the study, although they state that they are working on such a provision. The company is also planning a pediatric study and further adult studies. II trials are expected to begin in the fourth quarter of 1996. Dr. Mark Klein of the Texas Children's Hospital will be the lead investigator. Also, a clinical endpoint study for children is planned for late 96 or early 97.
Discussions are underway for a pharacokinetics study in newborns.
Although the data accumulated to date are promising, more research is necessary to confirm the efficacy and safety of this drug. It would be very important for individuals who have few or no treatment options left to be able to combine 1592 with protease inhibitor treatment.