ANSWERS
09/01/1995

<TITLE> FDA EXPANDS ACCESS TO INVESTIGATIONAL TREATMENT FOR CMV
RETINITIS </TITLE>
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T95-45                                       Ivy Fleischer Kupec
Sept. 1, 1995                                (301) 443-3285

FDA EXPANDS ACCESS TO INVESTIGATIONAL TREATMENT FOR CMV RETINITIS
     FDA today authorized treatment IND status for intravenous
cidofovir (Vistide) for HIV-infected persons with relapsing
cytomegalovirus (CMV) retinitis that has progressed despite
treatment.  CMV retinitis is an eye infection that can lead to
blindness in individuals with impaired immune systems, as is the
case with AIDS.  The following can be used to answer questions.
     FDA established the treatment IND mechanism for patients
suffering from serious or life-threatening conditions who have
exhausted existing treatments or have no satisfactory treatments. 
The treatment IND process allows them to obtain promising
experimental drugs that have undergone sufficient clinical testing
to show that they may be safe and effective.  In this case, FDA
granted expanded access, based on a controlled clinical trial that
indicated that intravenous cidofovir may slow the progression of
CMV retinitis.
     FDA has already approved two drugs for treating CMV retinitis:
foscarnet and ganciclovir.  Neither drug cures CMV retinitis, but
they can significantly delay disease progression.
     Gilead Sciences Inc. of Foster City, Calif., is making the
drug available free of charge in this treatment IND program,
starting Sept. 5.  At that time, patients and health care
professionals can obtain more information about the treatment IND
and its enrollment criteria by calling 1-800-GILEAD 5.  For more
information on other AIDS clinical trials, call 1-800-TRIALS-A.

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