      Document 0238
 DOCN  DRG0238
 UNIQUE IDENTIFIER        DRG-0009
 NAME OF SUBSTANCE        AL 721 [Merck Index 1989]
 REGISTRY NUMBER          99751-63-0
 STANDARD CHEMICAL NAME   AL 721 [CHEMLINE]
 SYNONYMS                 AL-721 [CHEMLINE]
 SYNONYMS                 Active Lipid [Merck Index 1989]
 SYNONYMS                 Altrigen [Merck Index 1989]
 PROTOCOL ID NUMBERS      NIAID ACTG 022
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Reduces the cholesterol
                          content of certain membranes, causing
                          membrane fluidization, which affects the
                          viral membrane organization and protein
                          structure; postulated that it could interfere
                          with the attachment, penetration, and release
                          of HIV. [Proc Annu Meet Am Soc Clin Oncol
                          1988;7:A18]
 DISEASES STUDIED/TREATED Persistent generalized lymphadenopathy [NIAID
                          ACTG 022]
 DISEASES STUDIED/TREATED Symptomatic HIV infection [NIAID ACTG 022]
 CLASSIFICATION CODE      Antiretroviral [Drug Evaluations Annual 1995]
 OTHER MAJOR USES         Nutritional supplement [Merck Index 1989]
 ADVERSE EFFECTS          May cause gastrointestinal disturbances
                          (diarrhea, nausea, vomiting, abdominal pain)
                          in patients at higher doses. Considered to be
                          nontoxic and safe at single oral doses up to
                          60 g. [NIAID ACTG 022] [Int Conf AIDS 1989
                          Jun 4-9;5]
 CONTRAINDICATIONS        Should not be used by pregnant or lactating
                          women or by people with significant cardiac,
                          liver, renal, or neurologic disorder. [NIAID
                          ACTG 022]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Contains neutral
                          glycerides, phosphatidylcholine and
                          phosphatidylethanolamine in 7:2:1 ratio
                          [Merck Index 1989]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Polyethylene-lined aluminum foil
                          sachets reconstituted in orange juice. [NIAID
                          ACTG 022]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Oral. [NIAID ACTG 022]
 SUBSTANCE DELIVERY DATA  STORAGE: Store in freezer until
                          reconstitution. [NIAID ACTG 022]
 MANUFACTURERS            Ethigen
 REFERENCES               Mildvan D, Buzas J, Armstrong D, Antoniskis
                          D, Sacks HS, Rhame FS, Mosbach FW, Pettinelli
                          C. An open-label, dose-ranging trial of AL
                          721 in patients with persistent generalized
                          lymphadenopathy and AIDS-related complex. J
                          Acquir Immune Defic Syndr. 1991;4(10):945-51.
 REFERENCES               Yust I, Vardinon N, Zacut V, Hasner A, Burke
                          M. AL721 reduces HIV antigenemia in
                          seropositive asymptomatic subjects. Int Conf
                          AIDS. 1991 Jun 16-21;7(2):223 (abstract no.
                          W.B.2167).
 REFERENCES               Wolf R, Ophir J, Yust I. Atopic dermatitis
                          provoked by AL721 in a patient with acquired
                          immunodeficiency syndrome. Ann Allergy. 1991
                          May;66(5):421-3.
 REFERENCES               Shinitzky M, Skornick Y. Suppression of HIV
                          antigenaemia by AL721 [letter; comment].
                          Lancet. 1990 May 26;335(8700):1281-2.
 REFERENCES               Peters BS, Bennett JM, Jeffries DJ, Knox K,
                          Kocsis A, Pinching AJ. Ineffectiveness of
                          AL721 in HIV disease [letter]. Lancet. 1990
                          Mar 3;335(8688):545-6.
 REFERENCES               Yust I, Vardinon N, Skornick Y, Zakuth V,
                          Hasner A, Shinitzky M. Reduction of
                          circulating HIV antigens in seropositive
                          patients after treatment with AL-721. Isr J
                          Med Sci. 1990 Jan;26(1):20-6.
 REFERENCES               Mildvan D, Armstrong D, Antoniskis D, Sacks
                          H, Balfour H, Buzas J, Pettinelli C. An open
                          label dose-ranging trial of al721 in pg1 and
                          ARC. Int Conf AIDS. 1989 Jun 4-9;5403
                          (abstract no. W.B.P.312).
 ENTRY MONTH              8906
 LAST REVISION DATE       960310
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
