Date: Wed, 3 Apr 1996 11:22:27 +0500
From: "Flynn Mclean" <Flynn_Mclean_at_NAC__PO@smtpinet.aspensys.com>
Subject: New Protocol Record 04/03/96

April 3, 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.

A description of the most recent clinical trial added to the
ACTIS database is 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 254A.

TITLE:    A Randomized Open Comparative Multicenter Study of
          Initial Treatment With Intravenous Itraconazole Versus
          Amphotericin B Followed by Consolidation Treatment With
          Itraconazole Capsules in Patients With Blastomycosis or
          Histoplasmosis.

PHASE:   Phase III.

DISEASE STATUS:
          Patients have the following symptoms and conditions: 1.
          HIV positive or negative.  2. Blastomycosis or
          histoplasmosis.

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

SPECIFICATION CRITERIA:
   Patients must have:
   1. HIV positive or negative status.
   2. Blastomycosis or histoplasmosis.
   3. Life expectancy of at least 1 week.

AGE:  13 Years - 99 Years.
SEX:  M. F.

REPRODUCTIVE SPECIFICATION:
   Not pregnant.  Not breast-feeding.

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

CD4 (T4 CELL) COUNT:     Unspecified cells/mm3.
BILIRUBIN:               < 3 mg/dl.
SGOT (AST):              <= 5 x ULN. (ULN = upper limit of
                         normal).
SGPT (ALT):               <= 5 x ULN.
CREATININE:               <= 4.0 mg/dl.


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

SPECIFICATION CRITERIA:
   Patients with the following prior condition are excluded:
   Hypersensitivity to azole antifungals.

AGE:  01 Days - 12 Years.

REPRODUCTIVE SPECIFICATION:
   Pregnant.  Breast-feeding.  Reproductive potential.

PRIOR MEDICATION:
   Excluded at any time:
   More than 3 days of amphotericin B, fluconazole, or
ketoconazole.
   Excluded within 2 weeks prior to study entry:
   1. Phenytoin.
   2. Phenobarbital.
   3. Rifampin.
   4. Rifabutin.

CONCURRENT MEDICATION:
   Excluded at any time:
   1. Terfenadine.
   2. Astemizole.
   3. Oral midazolam.
   4. Triazolam.
   5. Cisapride.
   6. Phenytoin.
   7. Phenobarbital.
   8. Rifampin.
   9. Rifabutin.
   Excluded during oral consolidation:
   1. H2 blockers.
   2. Chronic antacids.
   3. Omeprazole.
   4. Lansoprazole.


CO-EXISTING CONDITIONS OR DISEASES:
   Patients with the following symptoms or conditions are
excluded:
   1. Liver disease.
   2. Self-limiting fungal disease.
   3. Very severe fungal disease such as meningeal involvement.
   4. Acute respiratory disease.


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

   Drug 1: Itraconazole. Antifungal.
   Drug 2: Amphotericin B. Antifungal.


                              DRUG TRADE NAME
                              ---------------

   Drug 1: Sporanox.


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

   Drug 1: Janssen Research Foundation
   1125 Trenton-Harbourton Road
   Titusville, NJ 08560-0200
   Contact: Professional Services Depart      (800) 253-3682.
   Drug 2: Drugs are provided by each participating unit site.


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

   0000003150:
   University of Arkansas for Medical Sciences
   4301 West Markham Street / Mail Slot 639
   Little Rock, AR 72205
   Contact: Robert W Bradsher Jr         (501) 686-5585
   OPEN 960401.

   0000002399:
   Wishard Memorial Hospital / Indiana Univ School of Medicine
   1001 West 10th Street / OPW 430
   Indianapolis, IN 46202
   Contact: Beth Zwickl                  (317) 274-8456
   Contact: Heather Nixon                (317) 274-8456
   OPEN 960401.

   0000003177:
   Ann Arbor Veterans Administration Medical Center
   2215 Fuller Road / Room 839-A
   Ann Arbor, MI 48105
   Contact: Heidi Geutsch                (313) 761-7984
   OPEN 960320.

   0000003179:
   Infectious Diseases Association / Research Medical Center
   2316 East Meyer Boulevard / Room 357
   Kansas City, MO 64132
   Contact: Barbara Lee                  (816) 276-4038
   OPEN 960401.

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