      Document 0160
 DOCN  DRG0160
 UNIQUE IDENTIFIER        DRG-0087
 NAME OF SUBSTANCE        Anti-HIV immune serum globulin (Human) [FDA
                          060A]
 SYNONYMS                 HIVIG [AIDS Res Hum Retroviruses 1992
                          Aug;8(8)]
 SYNONYMS                 HBIG [FDA 060A]
 PROTOCOL ID NUMBERS      FDA 060A
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: HIVIG kinetics are typical of
                          immune globulins. HIVIG is safe in persons
                          with AIDS [FDA 060A] A Phase I clinical trial
                          of HIVIG in persons with AIDS showed mean
                          antibody changes (pre to 24h post dose) after
                          the 2 low and 2 high doses were,
                          respectively: total IgG rise .64, 2.63 g/L
                          and anti-p24, 5436, 19199. Mean T1/2 of
                          anti-p24 after dose 4 was 15.9 days. CD4
                          count and beta-2 microglobulin pre 1st dose
                          and 28d post 4th dose were HIV Ag pos pre 1st
                          dose, HIV Ag became undetectable and the
                          antip24 T1/2 was shorter. Paired plasma HIV
                          cultures pre and 24h post dose were available
                          for 37/48 doses: 20 were +/+, 5 +/-, 3 -/+,
                          12 -/-. Of 7 1st dose +/+ pairs, the post
                          dose time to positivity was equal or longer
                          in all (mean 8.9d to 17.9d). [Int Conf AIDS
                          Jun 20-23;6(3): (abstract no S.B. 500)] [FDA
                          060A]
 DISEASES STUDIED/TREATED Enhancement of immune function in HIV
                          infection. Under investigation for prevention
                          of maternal-fetal HIV transmission [FDA 060A;
                          NIAID ACTG 185]
 CLASSIFICATION CODE      Immunomodulator [FDA 060A]
 SUBSTANCE INTERACTIONS   Possibly interacts with immunomodulating
                          agents, steroids, and interferons. [FDA 060A]
 ADVERSE EFFECTS          Toxicities reported in a Phase I trial:
                          lightheadedness, reversible pneumocystosis,
                          and wasting. [Int Conf AIDS 1990 Jun
                          20-23;6(3): (abstract no. S.B. 500)]
 CONTRAINDICATIONS        Contraindicated in the presence of
                          HIV-induced neurological disease, or in
                          patients who are IgA negative. [FDA 060A]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Anti-HIV immune serum
                          globulin is derived from the plasma of
                          asymptomatic patients who demonstrate HIV
                          antigens and from plasma from HIV culture
                          negative HIV infected persons with high
                          anti-p24 antigen titer [FDA 060A]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The fraction is inactivated
                          with 1 percent tri-N-butyl phosphate and cold
                          alcohol and fractionated to produce the final
                          HIVIG product [FDA 060A]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Fraction of immune
                          globulin (human) [FDA 060A]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intravenous infusion. [FDA
                          060A]
 MANUFACTURERS            Abbott Laboratories
 REFERENCES               Eichberg JW, Murthy KK, Ward RH, Prince AM.
                          Prevention of HIV infection by passive
                          immunization with HIVIG or CD4-IgG. AIDS Res
                          Hum Retroviruses. 1992 Aug;8(8):1515.
 REFERENCES               Prince AM, Reesink H, Pascual D, Horowitz B,
                          Hewlett I, Murthy KK, Cobb KE, Eichberg JW.
                          Prevention of HIV infection by passive
                          immunization with HIV immunoglobulin. AIDS
                          Res Hum Retroviruses. 1991 Dec;7(12):971-3.
 REFERENCES               Rhame FS, Goodroad BK, Cummins LM, Fletcher
                          CV, Henry K, Shah N, Condie RM, Balfour HH
                          Jr, Allain JP. Phase I trial of HIV immune
                          globulin in persons with AIDS. Int Conf AIDS.
                          1990 Jun 20-23;6(3):211 (abstract no.
                          S.B.500).
 REFERENCES               Eichberg JW. Experience with thirteen HIV
                          efficacy trials in chimpanzees. Int Conf
                          AIDS. 1990 Jun 20-23;6(1):204 (abstract no.
                          Th.A.338).
 REFERENCES               Hewlett IK, Epstein JS, Hawthorne CA,
                          Eichberg J, Prince AM. Evaluation by PCR of
                          HIV-1 status of chimpanzees challenged with
                          HIV after receiving human HIVIG. Int Conf
                          AIDS. 1989 Jun 4-9;5:529 (abstract no.
                          W.C.O.27).
 REFERENCES               Eichberg JW. Experience with eight
                          HIV-vaccine trials in chimpanzees. Int Conf
                          AIDS. 1989 Jun 4-9;5:513 (abstract no.
                          M.C.O.26).
 ENTRY MONTH              9007
 LAST REVISION DATE       960604
 

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