ACTG Highlights

Of Clinical

ARB also expects to award five cooperative agreements this fiscal year to develop
and improve diagnostic tests for several opportunistic and sexually transmitted viral
infections, including CMV, HSV, VZV, and EBV, and non-viral infections, including
gonorrhea, syphilis, and chlamydia.
The ARB interacts closely with DAIDS staff to ensure that therapies with clinical
potential for people with AIDS are identified and evaluated expeditiously.
Mycoses Study Group
Clinical trials for fungal diseases differ from those for most bacterial and viral
diseases in three principal ways. In general, therapy of most systemic mycoses must be
administered over months to years, in contrast to viral or bacterial infections where
duration of treatment ranges from a few days to a maximum of 2 months. Similarly, posttherapy evaluations in systemic mycotic diseases must be extended up to one year, much
longer than for bacterial or viral infections, to adequately assess for relapse. Finally,
because of the lower incidence of systemic mycoses in the population, fewer patients are
available for recruitment and evaluation.
The Mycoses Study Group (MSG) is an NIAID-sponsored nationwide network of
medical centers dedicated to clinical research on serious fungal diseases. William E.
Dismukes, M.D., of the University of Alabama at Birmingham, serves as its director.
During its initial contract period, from 1978 to 1984, the MSG focused on clinical trials in
non-AIDS patients with systemic mycoses. During the second contract period, from 1985
to 1990, the MSG expanded its activities to include both non-AIDS and AIDS populations.
Over the past 11 1/2 years, the MSG has completed 8 clinical trials. Another 13
are currently ongoing. The MSG has carried out five studies exclusively in AIDS patients;
four of these studies were run jointly by the ACTG and the MSG. Active participation by
the MSG has been key to adequate patient enrollment in several of these studies.
Of the five studies that include only AIDS patients, three that are now closed tested
fluconazole as a treatment for crytococcal meningitis. Based on preliminary results of one
of these studies, NIAID issued in May 1990 a recommendation that fluconazole replace
amphotericin B as the treatment of choice for preventing recurrences of cryptococcal
meningitis. Fluconazole proved to be just as effective as amphotericin B and less toxic.
The two other studies, currently open, are testing SCH39304 for cryptococcal meningitis
and itraconazole for histoplasmosis.
In addition to these studies conducted exclusively in AIDS patients, the MSG has
also conducted three studies for coccidioidomycosis involving both AIDS and non-AIDS
patients. Future plans include studies of blastomycosis, sporotrichosis, aspergillosis, and
candidemia.