Searchlight Vol. 3, no. 1

SEARCH Trials At A Glance

An Important Notice About SEARCH Alliance Research:
SEARCH Alliance research usually differs from traditional research in
many important ways. Traditional research, which is performed by
government agencies, universities, and many community organizations, usually involves large numbers ofpatients, takes a long time, and
costs a great deal of money. It is necessary that traditional research be
done in this manner because the benefits ofAIDS medications are often
very subtle and might not be seen otherwise.
SEARCHAlliance trials involve smaller numbers ofpatients and much
shorter periods of examination than traditional research. We limit our
research to drugs and treatments that may clearly and quickly show
benefit. While we believe that both types of research are important, the
people involved with SEARCHAlliance are specifically looking to benefit
those who need help now.
The decision to enroll in a particular research project should only be
made after a detailed discussion with your personalphysician. Ifyou
want to participate in any of these trials, you or your doctor are
encouraged to call SEARCHAlliance at [phone] or
1-800-64-SEARCH for further information.
SEARCH Project 92-2
Cimetidine (Tagamet~)
Purpose: To determine if cimetidine has an immune-stimulating effect
through its proposed action of blocking histamine receptors on lymphocytes. It is a histamine H2 receptor antagonist, and is used most commonly
to treat peptic ulcer disease. In addition to monitoring CD4 and CD8 cell
counts, there will also be monitoring of immune status improvements
through the use of delayed-type hypersensitivity skin testing.
Status: This trial is fully enrolled. The results of the interim analysis will be
reported as soon as they become available.
SEARCH Project 91-4
Human Growth Hormone BioTropinTM (hGH)
Purpose: Synthetic human growth hormone is a recombinant DNA polypeptide, whose amino acid sequence is identical to that of human growth hormone of pituitary origin. HGH has been shown to regenerate the atrophied
thymus and subsequent T-cell re-populations in animal models. This new
population of T-cells is not only increased in number but in efficacy as well.
HGH also increases the amount of interleukin-2 (IL2) and alpha interferon,
two vital substances whose levels are below normal in HIV positive individuals.
Status: This trial is currently open. There are two slots available for individuals who are HI positive and have CD4+ counts between 300 and 500.
Please contact Paul Lukacs at the SEARCH Alliance office for enrollment
information.
ACCELERATED PILOT STUDIES
Lymphocyte Transfer as Immune Therapy
Purpose: To determine the potential therapeutic effects of transfusing

lymphocytes from a monozygotic (identical) twin who is HIV negative to the
other twin who meets the criteria of AIDS. This research holds promising
implications for similar treatments with non-twin siblings.
Status: The initial phase of this trial has been completed and six transfers of
lymphocytes have taken place, were well-tolerated, and the patient speaks of
feeling much better post-infusion. The study results are as follows: the HIV
positive twin had an undetectable number of CD4 cells at baseline (essentially 0) and this was increased to 35 at four weeks and was at 50 after six
weeks. The CD8 counts went from 210 to 620 to 380 during the same time
period. The clinical and other laboratory information are being reviewed
for other potential therapeutic indicators. SEARCH Alliance is considering a
second protocol to test the viability of transfused lymphocytes.
Shark Cartilage
Background: Shark cartilage contains a vascularization-inhibiting agent that
may be potentially useful in treatment of tumors and Kaposi's sarcoma.
Status: This is an on-going study at the Keith Medical Group. Please contact
their office for more information [phone].
Immunoglobulin to Alpha Fetoprotein
Background: There are several functional similarities between the binding
sites of human alpha fetoprotein (AFP) and HIV glycoproteins, those proteins that coat the virus. It has been demonstrated that immunoglobulin to
AFP inhibits syncytial formation and prevents HIV replication in cells invitro. This immunoglobulin was administered to patients with advanced
liver cancer during the early 1980s with no significant side effects.
Status: This trial is fully enrolled. We are conducting an accelerated pilot
study of the immunoglobulin to AFP in order to assess a number of endpoints including CD4+ counts and viral load.

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SEARCHLIGHT January/February,1993

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