Treatment Review No. 14; November 1994

In one prevention study sponsored by Syntex, which makes the drug, participants with T4 cell counts of less than 100 were given the pill form of ganciclovir or a placebo. All studies are overseen by Safety Monitoring Boards. In this case, the study was stopped by its Data Safety Monitoring Board because there was less CMV disease, including CMV retinitis, seen in the participants who were getting the drug. Everybody on the study has now been given the drug, and they are still being followed to see if the drug continues to work. The study has been changed from a randomized to an open-label trial where everyone knows which treatment they are getting.

CPCRA (Community Program for Clinical Research on AIDS) is an organization that does community based clinical trials at sites where people go for their primary care. An ongoing trial being done by the CPCRA to see if oral ganciclovir can prevent CMV retinitis has been changed so that people can either choose to get the drug or continue to be blinded, not knowing if they are getting the real drug or placebo. This trial is filled.

Syntex has asked the U.S. Food and Drug Administration (FDA) to allow them to sell oral ganciclovir for maintenance treatment of CMV disease based on earlier studies. This would be for continuing treatment after an active infection has already been brought under control. It is hoped Syntex will amend this request so that oral ganciclovir can be used for prevention of CMV disease as well.

Oral ganciclovir is currently available from the drug company through an expanded access program for the maintenance treatment of CMV retinitis. You must have a history of having had a permanent central intravenous catheter removed at least twice within the previous six months due to catheter infection or thrombosis, or have a medical condition that would make placement or use of a permanent catheter inappro-priate or unfeasible. Enrollment into the expanded access program is through any licensed physician. Doctors can call (800) 569-4630 for information. Clinic visits are required at study entry, week 2, week 4, and every 4 weeks thereafter. Minimal ophthalmologic, current medication, and lab information will be collected at every visit. This is an open- label protocol, so all participants will know which treatment they are getting.

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