FYI
by Debbie Bell R.N.
New Clinical Trials in Cleveland
There are some very important and interesting clinical
trials that are about to start at University Hospitals and The
Cleveland Clinic which I'd like to highlight. Immune
restoration is a critical goal for long term survival to be
associated with the quality of life. Results of recent
clinical trials of "highly active antiretroviral therapies",
or HAART, leads to partial immune restoration in moderately
advanced HIV disease after 12 weeks. A healthy immune system
recognizes "intruders" to the body, like bacteria, viruses and
cancers, and destroys them. In HIV disease, the immune system
fails to recognize these intruders as harmful, and they can
grow unchecked in the body. It was hoped that immune system
restoration seen with HAART would lead to an improvement in
the body's ability to recognize foreigners, but so far this
has not been seen. Thus , finding other ways of restoring the
immune system has become a paramount focus of clinical study.
Earlier trials have indicated that intermittent high dose
infusion of interleukin-2 in persons with relatively high CD4
(T cell) counts dramatically increased the amount of
circulating CD4 cells. The infusion was given every two
months, but it is now thought the interleuken effect is so
durable that it could be be given less often and still work
well. Clinical trial #328 will ask if this increase in CD4
counts will be seen in those considerably more
immunosupressed, with CD4 counts from 50 to 300. Participants
must not have taken a protease inhibitor as yet. All
participants will receive, ddI + d4T + Crixovan, +/-
interleuken-2 for up to 72 weeks.
It has recently been clarified that HIV needs an active
immune system to be active itself. If the immune system is
quiet, HIV is quiet. Anything that stimulates he immune
system, like a cold or allergies, will stimulate HIV
production. This has lead to the question: "Should we
deliberately suppress the immune system to keep HIV production
down?" Sounds crazy, doesn't it, yet this is exactly what is
being studied in trial #334. Along these same lines, the
Cleveland Corticostroid Trial is starting at the Cleveland
Clinic in which participants with CD4 counts less than 200
will receive either prednisone or placebo for 8 weeks. The
goal is to see if these doses of prednisone decrease Tumor
Necrosis Factor, associating with wasting, decrease HIV viral
load and increase CD4 counts. A similar trial begins at UH in
3 Months.
For further info contact Margaret Cutler RN, or Michael
Chance at (216) 368-AIDS (2437).
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