Date: Tue, 27 Feb 1996 15:36:39 +0500
From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com
Subject: New Clinical Trials Info 02/27/96


February 27, 1996

                     NEW INFORMATION FROM ACTIS

The AIDS Clinical Trials Information Service (ACTIS) is a
central resource providing current information on federally and
privately sponsored clinical trials for AIDS patients and others
infected with HIV.  This service is a Public Health Service
project produced collaboratively by the Centers for Disease
Control and Prevention, the Food and Drug Administration, the
National Institute of Allergy and Infectious Diseases, and the
National Library of Medicine.  NAC ONLINE, the computerized
information service of the CDC National AIDS Clearinghouse, will
alert you to any new information collected by ACTIS.

Descriptions of the most recent clinical trial and new drug added
to the ACTIS database are provided below.

For more information, call the ACTIS toll-free number to talk
with a health specialist.  On request, you can also obtain a
printout of a customized search of the clinical trials databases.

The information can also be accessed directly by subscribers
through two online databases, AIDSTRIALS and AIDSDRUGS, available
through the National Library of Medicine.

                AIDS CLINICAL TRIALS INFORMATION SERVICE
                             1-800-TRIALS-A
                            (1-800-874-2572)
                           FAX: 1-301-738-6616
                         TTY/TDD: 1-800-243-7012
                   International Line: 1-301-217-0023

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  PROTOCOL NUMBER:  FDA 253B.

  TITLE:   Open-Label Compassionate Use of Nitazoxanide for the
           Treatment of Cryptosporidiosis in AIDS Patients.

  DISEASE STATUS:
      Patients have the following symptoms and conditions: 1.
      AIDS.  2. Diagnosis of cryptosporidial diarrhea defined by
      presence of Cryptosporidium oocysts in stool specimens and
      chronic diarrhea (4 or more bowel movements daily for at
      least 2 weeks).  3. Failed prior cryptosporidiosis therapy.
      4. NO history of intestinal Mycobacterium
      avium-intracellulare infection.  5. NO history of
      intestinal Kaposi's sarcoma.

                   PATIENT INCLUSION CRITERIA
                   --------------------------

  SPECIFICATION CRITERIA:
     Patients must have:
     1. AIDS.
     2. Refractory cryptosporidial diarrhea.
     4. NO history of intestinal Mycobacterium
     avium-intracellulare infection or intestinal Kaposi's
     sarcoma.

  AGE:  15 Years - 65 Years.
  SEX:  M. F.

  REPRODUCTIVE SPECIFICATION:
     Not pregnant.  Negative pregnancy test within 14 days of
     study entry. Abstinence or effective method of birth control
     / contraception including oral contraceptives during the
     study.

  CONCURRENT MEDICATION:
     Allowed: Prophylaxis or maintenance for opportunistic
     infections, provided dosage regimen has been stable for at
     least 2 weeks prior to study entry.


                           LABORATORY VALUES AT ENTRY
                           --------------------------

  CD4 (T4 CELL) COUNT:             <= 200 cells/mm3. (0 - 100 -
                                   200).  > 200 cells/mm3 is
                                   allowed ONLY IF patient has
                                   had cryptosporidiosis for at
                                   least 2 weeks. (300- 400 - 500
                                   - 600 - 700 - 800 - plus).


                           PATIENT EXCLUSION CRITERIA
                           --------------------------

  SPECIFICATION CRITERIA:
     Patients with the following prior conditions are excluded:
     History of Cytomegalovirus colitis unless 28 days of therapy
     with ganciclovir or foscarnet was completed prior to
     diagnosis of cryptosporidiosis.
     [Refer to Laboratory values for additional requirements.]

  AGE:  01 Days - 14 Years. 66 Years - 99 Years.

  REPRODUCTIVE SPECIFICATION:
     Pregnant.  Positive pregnancy test within 14 days of study
     entry.  No abstinence or no agreement to use effective
     method of birth control / contraception during the study.

  PRIOR MEDICATION:
     Excluded: Investigational drug therapy within 14 days prior
     to study entry, unless available under FDA-authorized
     expanded access program.

  CONCURRENT MEDICATION:
     Excluded:
     1. Drugs with possible anti-cryptosporidial activity, such
     as paromomycin, spiramycin, azithromycin, clarithromycin,
     hyperimmune bovine colostrum.
     2. Experimental agents used to treat microsporidiosis, such
     as albendazole.


  CO-EXISTING CONDITIONS OR DISEASES:
     Patients with the following symptoms or conditions are
     excluded: Salmonella, Shigella, Campylobacter, Yersinia,
     Giardia lamblia, Entamoeba histolytica, Isospora,
     Cyclospora, or Clostridium difficile toxin in stool.


                               GENERIC DRUG NAME
                               -----------------

     Drug 1: Nitazoxanide. Antiparasitic.


                                 DRUG COMPANIES
                                 --------------

     Drug 1: Unimed Pharmaceuticals Inc
     2150 East Lake Cook Road
     Buffalo Grove, IL 60089
     Contact: Sandy Faulkner               (800) 864-6330 X 3032.


                              PARTICIPATING UNITS
                              -------------------

     0000003497:
     Unimed Pharmaceuticals Inc
     2150 East Lake Cook Road
     Buffalo Grove, IL 60089
     Contact: Sandy Faulkner               (800) 864-6330 X 3032
     OPEN / USA accrual 960131.

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