Clinical Trial Review, no. 3

U".

IiriicziI Friil

A PREVENTION
STRATEGY
Both CMV and MAC are diseases
which people with less than 100 T4
cells maydevelop. Two studies which
are described in this review, ACTG
193 and ACTG 204, are designed to
prevent the development of these
diseases in people who are at risk. It
is possible to participate in BOTH of
these studies at the same time. Most
places where these studies are taking place are conducting both studies. Although the same person may
not be conducting the study, you can
ask to participate in both of them.
The different study coordinators can
work out the arrangements. This
should not involve major time or
energy. If the same person is running both studies it should be very
easy. The benefit of doing this is that
you may be preventing two diseases
at once. Of course, the information
which is gathered from these studies will greatly help everyone living
with H IV disease. Thinkabout it, and
call us if you want to talk about it.
Mepron Approved
(PCP Treatment)
The drug Mepron (also called 566 or
Atovaquone) has been approved by
the FDA for the treatment of mild to
moderate PCP pneumonia for people
who are intolerant to standard treatments. This drug, which is made by
Burroughs-Wellcome, is taken by
mouth. For more information on
Mepron contact The Network. This
drug is now available by prescription.

MSL-109 for CMV Retinitis
MSL-109, also called HMA-CMV (human monoclonal antibody to cytomegalovirus), is an immunomodulator being studied as a treatment for CMV
retinitis, an infection which often leads to blindness in persons with AIDS. In
vitro, MSL-109 has been shown to attach to CMV-infected cells. No major
side effects were noted in animals or bone-marrow transplant patients.
FDA 071 B is a Phase 1/11 trial to assess the safety and tolerance of different
amounts of MSL-1 09 in people with AIDS and CMV retinitis. You must have
completed one course of ganciclovir treatment, and be readyto continue. You
cannot be pregnant. Various medications for treatment of other conditions are
allowed.
Oral Ganciclovir
Ganciclovir (Cytovene) is a drug approved for the treatment of CMV retinitis.
Ganciclovir can cause neutropenia (low white blood cell count) and other
dose-limiting toxicities. Ganciclovir is only approved as an intravenous drug,
but an oral compound of the same drug is under study.
The oral form of ganciclovir is being tested as prophylaxis in people who are
at risk. Earlier studies indicate that the oral form of the drug may not be
absorbed well enough to treat CMV disease, although it may be useful when
the CMV virus is less aggressive.
Syntex 1654 is a double-blind placebo controlled study of oral ganciclovir as
a prophylaxis against CMV infection. The doses are 500, 750, and 1000 mg
every 8 hrs. Sites include Atlanta, San Francisco, and the East Bay AIDS
center in Berkeley. The study will last for up to 18 months.
To participate in this study, you must be CMV antibody positive, although not
have current or previous CMV disease. You must have T4 counts of less that
100, and you cannot have used any anti-CMV drugs within the last 60 days.
Zovirax (Acyclovir)
On December 7, Burroughs Wellcome, the company that makes acyclovir
(Zovirax), a drug used for treatment of severe herpesvirus infections, announced that it will cap the price of the drug for patients who pay for it
themselves. The program began January 1, 1993.
Health care professionals can call Burroughs Wellcome at 800.722.9294 for
more information about this program and how to register patients. People who
use more than 730 grams in one year, for which Burroughs Wellcome charges
wholesalers about $2,500, can receive up to an additional 730 grams at no
cost. This program is only for patients who do not have third-party coverage
for acyclovir.

AIDS Treatment Data Network

February 1993

11