Treatment Review No. 14; November 1994
Ganciclovir is a drug used to treat CMV. CMV, which stands for
cytomegalovirus, is a serious opportunistic infection that can
lead to blindness and can also affect the intestines and lungs.
Ganciclovir is given by IV injection, and requires permanent
placement of a catheter. A pill form of the drug has been in
studies both for prevention of CMV disease, and as a
maintenance treatment. Maintenance treatment is to keep disease
from spreading once it is under control. Oral ganciclovir is
being studied to see if it can help prevent CMV disease.
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.