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$Unique_ID{BRK02993}
$Pretitle{}
$Title{AIDS (Acquired Immune Deficiency Syndrome), part II}
$Subject{AIDS (Acquired Immune Deficiency Syndrome) AIDS DISORDER SUBDIVISIONS
AIDS AIDS related complex, also known as ARC, AIDS prodrome, Wasting/Lymph
Node Syndrome, and Mini-AIDS}
$Volume{}
$Log{}
Copyright (C) 1986, 1987, 1990, 1991, 1992, 1993 National Organization
for Rare Disorders, Inc.
78:
AIDS (Acquired Immune Deficiency Syndrome), part II
** IMPORTANT **
It is possible that the main title of the article (Acquired Immune
Deficiency Syndrome) is not the name you expected. Please check the SYNONYMS
listing to find the alternate names and disorder subdivisions covered by this
article.
Therapies: Investigational
Tests to identify individuals infected with the AIDS virus before they
develop the disease have shown an increase in virus-infected white blood
cells in the year before AIDS symptoms become apparent. Since present tests
to detect these cells (peripheral blood mononuclear cells or monocytes) are
very time consuming and expensive, the Centers for Disease Control (CDC) is
trying to develop simpler tests. Treatments of AIDS when identified early
enough may be more effective than treating the disease after symptoms appear.
The experimental drug, Kemron, is being used in several African countries
as a treatment for AIDS. The drug was developed by the Kenya Medical
Research Institute. The World Health Organization (WHO) is conducting
studies with Kemron in several African countries.
Gene therapy is being investigated as a possible treatment for AIDS
patients; however, this type of therapy has so far only been tested in
animals.
The Food and Drug Administration (FDA) has given a 1987 Orphan Drug
research grant to John E. Conte, Jr., M.D. for studies on pentamidine
pharmacokinetics related to AIDS patients on hemodialysis. Another grant was
given for studies on the drug diethyldithiocarbamate for treatment of AIDS to
Evan M. Hersh, M.D., University of Arizona, Tucson, AZ.
ORPHAN DRUGS
Merrell Dow has been testing the experimental orphan drug Eflornithine
hydrochloride (DFMO) for treatment of pneumocystis pneumonia, a frequent
cause of death among AIDS patients. Preliminary studies indicate that 74% of
patients responded favorably to this treatment. DFMO does not affect the
AIDS itself; it simply alleviates this type of pneumonia which is often a
fatal complication of AIDS. For additional information about eflornithine
HCl (DFMO), physicians can contact:
Merrell Dow Research
P.O. Box 6300
2110 East Galbraith Road
Cincinnati, OH 45215-6300
Clinical trials are being conducted on the following orphan drugs for
treatment of AIDS. For additional information, physicians can contact (the
name of the drug proceeds the address):
Diethyldithiocarbamate (Imuthiol)
Merieux Institute, Inc.
7855 NW 12th St., Suite 114
Miami, FL 33126
2'3'-dideoxycytidine
The Division of Cancer Treatment
National Cancer Institute (NCI)
Bldg. 31, Rm. 3A49
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, MD 20892
Experimental Orphan Drugs for the treatment of AIDS include Spiramycin,
HPA-23 and others. Patients and doctors wishing to apply for admission into
clinical trials of any AIDS drug should call the FDA at 1-800-9388.
For additional information about HPA-23, physicians can contact:
Rhone-Poulenc Pharmaceuticals
Division of Rhone Poulenc, Inc.
P.O. Box 125
Black Horse Lane
Monmouth Junction, NJ 08852
Four other orphan drugs are being tested for treatments for AIDS patients
who develop Pneumocystic Carinii Pneumonia. Physicians can contact the
following companies for information on these orphan drugs (the name of the
drug proceeds the address):
Diethyldithiocarbamate (Imuthiol)
Merieux Institute, Inc.
7844 NW 12th St., Suite 114
Miami, FL 33126
Pentamidine isethionate (no brand name established)
Phone-Poulenc, Inc.
52 Vanderbilt Ave.
New York, NY
Pentamidine isethionate
LyphoMed, Inc.
2020 Ruby St.
Melrose Park, IL 61060
Trimetrexate glucuronate
Warner-Lambert Co.
2800 Plymouth Road
P.O. Box 1047
Ann Arbor, MI 48106
Two orphan drugs are undergoing clinical trials for treatment of AIDS-
related Kaposi's Sarcoma. For additional information, physicians can contact
(the name of the drug proceeds the address):
Interferon alfa-nf (Wellferon)
Burroughs Wellcome Co.
3030 Cornwallis Rd.
Research Triangle park, NC 27709
Interferon alfa-2b (Intron A)
Schering Corp.
2000 Galloping Hill Rd.
Kenilworth, NJ 07033
Reports about the possibility of the drug Cyclosporine being an effective
treatment for AIDS were released prematurely from researchers in France in
1985. This drug is commonly used to suppress the immune system in patients
who have received a transplanted organ. The French reports were issued after
the drug had been used for only 6 days on a very limited number of patients
all of whom died after transient initial improvement.
Tests are proceeding on an AIDS vaccine. If successful, the vaccine may
be available to the general public during the 1990's.
Due to the toxicity of Pentamidine when it is injected into the veins,
researchers are conducting studies on an aerosol form of the drug.
Preliminary results indicate that the drug may be as effective but less toxic
than the injectable drug.
For more information on AIDS, see the AIDS Update section listed on the
NORD Services menu.
For information on additional therapies that have been designated as
Orphan Drugs in the last few months, please return to the main menu of NORD
Services and access the Orphan Drug Database.
Investigational New Drugs (IND'S) for Opportunistic Infections and
Cancers as of 1990.
More than 80 ongoing human studies have been approved by FDA to test
potential drugs to treat opportunistic infections and cancers often found in
AIDS patients.
Anti-infective therapies and their sponsors include:
Trimetrexate, Warner-Lambert Co., Morris Plains, NJ, (201) 540-2000, and
National Institute of Allergies and Infectious Diseases (NIAID), Bethesda,
MD, (301) 496-5717, for PCP.
Eflornithine (DMFO), Merrell-Dow Pharmaceuticals Inc., Cincinnati, OH,
(513) 984-9111, for PCP.
Aerosol Pentamidine, Fisons Corporation, Bedford, MA, (617) 275-1000;
LyphoMed, Rosemont Park, IL, (312) 390-6500; and National Institute of
Allergies and Infectious Diseases (NIAID), Bethesda, MD, (301) 496-5717, for
PCP.
Foscarnet, Astra Pharmaceutical Products, Inc., Westboro, MA, (508), 366-
1100, and National Institute of Allergies and Infectious Diseases (NIAID),
Bethesda, MD, (301) 496-5717, for cytomegalovirus retinitis.
Ansamycin (in combination with other drugs), Adria, Laboratories, Dublin,
OH, (614) 764-8100, for mycobacterium avium intracellulare infection.
Spiramycin, Rhone-Poulenc, Inc., Monmouth Junction, NJ, (201) 297-0100,
for crytosporidiosis.
Piritrexim, Burroughs Wellcome Co., Research Triangle Park, NC, (919)
248-3000, for PCP.
Immune Globulin IG-IV, Sandoz Pharmaceuticals Corp., East Hanover, NJ,
(201) 396-7500; Alpha Therapeutics, Los Angeles, CA, (213) 227-7526; and
Miles, Inc., West Haven, CT, (203) 937-2205, for various opportunistic
infections. Also, National institutes of Health (NIAID), Bethesda, MD,
(301) 496-5717, and National Institute of Child Health and Human
Development, (NICHD), Bethesda, MD, (301) 496-5133 for prevention of various
opportunistic infections in children.
Fluconazole, Pfizer, Inc., New York, NY, (212) 573-2323, for esophageal
candidiasis and crytococcal meningitis.
Nystatin, Squibb Co., Princeton, NJ, (609) 921-4650, for oral candidiasis
prevention.
Clofazimine, San Francisco General Hospital, San Francisco, CA, (415)
821-5531, for mycobacterium avium intracellulare.
Sandostatin, Sandoz Research Institute, East Hanover, NJ, (201) 396-7500,
for AIDS-related diarrhea.
Diclazuril, Janssen Pharmaceutica, Piscataway, NJ, (201) 524-9591, for
crytosporidial diarrhea.
Dapsone, Jacobus Pharmaceutics, Princeton, NJ, (609) 921-7447, for PCP
prevention.
Clindamycin, mark Jabcobson, M.D., San Francisco, CA, for toxoplasmic
encephalitis.
Pyrimethamine (DARAPRIM), Burroughs Wellcome Co., Research Triangle Park,
NC, (919) 248-3000, for toxoplasmosis prevention.
Itraconazole (SPORANOX), Janssen Pharmaceutica, Piscataway, NJ, (201)
524-9591, for histoplasmosis.
Experimental immuno-modulating agents and their sponsors include:
Lymphoblastoid interferon, Burroughs Wellcome Co., Research Triangle
Park, NC, (919) 248-3000, for KS.
Experimental Anti-neoplastic agents and their sponsors include:
Piritrexim Isethionate, Burroughs Wellcome Co., Research Triangle Park,
NC, (919) 248-3000, for KS.
Doxorubicin, National Institute of Allergies and Infectious Diseases
(NIAID), Bethesda, MD, (301) 496-5717, for KS.
Tumor Necrosis Factor, Genentech, Inc., San Francisco, CA, (415) 266-
1000, for KS.
Menogaril, National Cancer Institute (NCI), Bethesda, MD, (301) 496-6641
for KS.
M-BACOD (with Retrovir), National Institute of Allergies and Infectious
Diseases (NIAID), Bethesda, MD, (301) 496-5717, for primary lymphoma.
Dr. Thomas J. Smith of the University of Kentucky Research Foundation in
Lexington, KY, has been awarded a New Grant Award from the Office of Orphan
Products Development in 1990. His work studies the linear release of
Ganciclovir in related CMV Retinitis.
The FDA has approved the following drugs for testing as treatments for
AIDS patients:
The orphan Dronabinol (Marinol) is being tested as a stimulation of the
appetite in AIDS patients. The drug is manufactured by Unimed, Inc.,
Somerville, NJ.
Lactobin is an orphan drug being tested to control diarrhea in AIDS
patients who don't respond to initial anti-diarrheal therapy. The drug is
manufactured by Roxane Laboratories, Columbus, OH.
Treatment of AIDS-related Pneumocystis carinii pneumonia with the orphan
drug 566C80 is being tested by Burroughs Wellcome, Co., Research Triangle
Park, NC, under the approval of the FDA.
The Public Health Services and the Centers for Disease Control (CDC) run
a toll free hotline (1-800-HIV-INFO) to provide information about A IDS and
referrals to local service providers.
The drug company, Genentech, Inc., 460 Point San Bruno Blvd., South San
Francisco, CA, 94080, is developing a new orphan drug, Recombinant Human CD4
Immunoglobulin G, for use in the treatment of AIDS resulting from infection
with the human immunodeficiency virus.
Treatment of Toxoplasmosis in AIDS patients with Poloxamer 331 (Protax)
is being tested. The drug is manufactured by Cytrx Corp., Norcross, GA.
Granulocyte-colony stimulating factor, recombinant-methionyl, trade name
Neupogen, is being tested for CMV-Retinitis in AIDS patients who are also
taking ganciclovir. The sponsor is Amgen, Inc., 1840 DeHavilland Dr.,
Thousand Oaks, CA, 91320-1789.
Gynex, Inc., 1175 Corporate Woods Parkway, Vernon Hills, IL, 60061, is
the sponsor for the new orphan therapy for AIDS patients with HIV Wasting
Syndrome. The trade name for the drug is Oxandrin (Oxandrolone).
Clinical trials are underway to study lymphoma, Kaposi's sarcoma and
secondary tumors in pediatric patients with AIDS. Interested persons may wish
to contact:
Dr. Yvonne J. Bryson
Dept. of Pediatrics
UCLA School of Medicine
10833 LeConte Ave.
Los Angeles, CA 90024
(213) 825-5235
to see if further patients are needed for this study.
Clinical trials are underway to study 2',3'-Dideoxyinosine (ddI)
administered orally twice daily to Zidovudine (ZDV) intolerant patients with
HIV infection. Interested persons may wish to contact:
Robert T. Schooley, M.D.
University of Colorado Health Sciences Center
Box B168
Denver, CO 80262
(303) 270-7233
to see if further patients are needed for this study.
The treatment of Cytomegalovirus Retinitis in AIDS patients with the
orphan drug SDZ-MSL-109 is being sponsored by Sandoz Pharmaceuticals Corp.,
59 Route 10, East Hanover, NH, 07936.
The orphan product, Somatropin for injection, is being studied for the
treatment of AIDS-associated weight loss. The drug is sponsored by Serono
Laboratories, Inc., 100 Longwater Circle, Norwell, MA, 02061.
The orphan product Cryptosporidium Hyperimmune Bovine Colostrum IgG
Concentrate, sponsored by Immucell Corp., 966 Riverside St., Portland, ME,
04103, has received testing permission from the FDA.
Dapsone USP has received orphan product from the FDA. The drug is
sponsored by Jacobus Pharmaceutical Co., P.O. Box 5290, Princeton, NJ, 08540.
The orphan product, Sermorelin Acetate for injection used for the
treatment of AIDS-associated catabolism/weight loss, is being sponsored by
Serono Laboratories, Inc., 100 Longwater Circle, Norwell, MA, 02061.
The orphan product Immupath is being studied as a treatment for AIDS.
The product is being sponsored by Hemacare Corp., 4954 Van Nuys Blvd.,
Sherman Oaks, CA, 91403.
The antiviral drug stavudine (d4T) is now available to more AIDS
patients, those who cannot tolerate other antiviral drugs or those who have
worsened while taking those drugs. Physicians may call Bristol-Myers Squibb
Co. at (800) 842-8036 for further information.
This disease entry is based upon medical information available through
March 1993. Since NORD's resources are limited, it is not possible to keep
every entry in the Rare Disease Database completely current and accurate.
Please check with the agencies listed in the Resources section for the most
current information about this disorder.
Resources
For more information on AIDS, please contact:
National Organization for Rare Disorders (NORD)
P.O. Box 8923
New Fairfield, CT 06812-1783
(203) 746-6518
Computerized AIDS Information Network (CAIN)
1213 North Highland Avenue
P.O. Box 38777
Hollywood, CA 90038
(213)464-7400, ext. 450
National Gay Task Force (NGTF)
80 Fifth Avenue, suite 1601
New York, NY 10011
Provides a handbook listing support groups, fund raising organizations,
etc.
National Hemophilia Foundation
19 West 34th Street
New York, NY 10001
(212) 563-0211
NIH/National Institute of Allergy and Infectious Diseases
9000 Rockville Pike
Bethesda, MD 20892
(301) 496-5717
Centers for Disease Control
1600 Clifton Road, NE
Atlanta, GA 30333
(404) 639-3534
National Sexually Transmitted Diseases Hotline
(800) 227-8922
American Social Health Association
100 Capitola Dr., Suite 200
Research Triangle Park, NC 27713
(919) 361-8400
Council for Sex Information and Education
444 Lincoln Blvd., Suite 107
Venice CA 90291
The AIDS Information Clearinghouse has been set up by the ICOA Health
Information Network to continuously provide updated information on AIDS to
the public. This electronic news and information service is available via
AT&T's ACCUNET packet or AT&T Mail and provides information on research,
screening and prevention programs, health care costs, confidentiality and
discrimination issues.
The National Cancer Institute has developed PDQ (Physician Data Query), a
computerized database designed to give doctors quick and easy access to many
types of information vital to treating patients with this and many other
types of cancer. To gain access to this service, a doctor can contact the
Cancer Information Service offices at 1-800-4-CANCER. Information
specialists at this toll-free number can answer questions about cancer
prevention, diagnosis, and treatment.
The National Library of Medicine has developed a computerized database
called AIDSLINE with scientific articles about AIDS. Health professionals
can request access to the database from the MEDLARS management section at 1-
800-638-8480.
Information on privately funded clinical trials of drugs and biologics
used to treat AIDS and AIDS-related illnesses is now available through a
toll-free telephone service. The toll-free telephone service is staffed by
specially trained information specialists, including some who speak Spanish.
Service for the hearing impaired is also available. Information from the
phone service is also accessible through DIRLINE, the National Library of
Medicine's online computer database.
All inquiries are kept confidential.
By dialing 1-800-TRIALS-A, callers can find out where studies are located
and the eligibility criteria for participants, the name of the product being
studied and the purpose of the study, and a contact person and phone number
for the company that is sponsoring the clinical trials.
References
Reports on AIDS Published in the Morbidity and Mortality Weekly Report
June 1981 through the present. Centers for Disease Control.
Justification of Appropriation Estimates for Committee on Appropriations.
Public Health Service Supplementary Budget Data (Moyer Material) A through L.
Fiscal Year 1986, Vol. VII. (This publication is available from the National
Institute of Health (NIH) and contains information on all AIDS research being
funded by NIH.)
National Institute of Health Conference. Acquired immunodeficiency
syndrome: epidemiologic, clinical, immunologic, and therapeutic
considerations. Fauci, A.S., et al. ANN INTERN MED 1983 Jan; 100(1):92-106.
Acquired Immunodeficiency Syndrome. Macher, A.M. AM FAM PHYSICIAN 1984
Dec; 30(6):131-44.
Acquired immune deficiency syndrome: an update and interpretation. Daul,
C.B., et al. ANN ALLERGY 1983 Sep; 51(3):351-61.
The acquired immune deficiency syndrome. Pinching, A.J. CLIN EXP
IMMUNOL 1984 Apr; 56(1):1-13.
Treatment of Kaposi's sarcoma and thrombocytopenia with vincristine in
patients with the acquired immunodeficiency syndrome. Mintzer, D.M., et al.
ANN INTERN MED 1985 Feb; 102(2):200-2.
Treatment of intestinal cryptosporidiosis with spiramycin. Portnoy, D.,
et al. ANN INTERN MED 1984 Aug; 101(2):202-4.