$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.