Phase I/II trial of HIV-1 hyperimmune globulin for the prevention of HIV-1 vertical transmission in Uganda.
OBJECTIVE
To assess the safety, tolerance, pharmacokinetics, and virologic and immunologic changes associated with the use of Ugandan HIV hyperimmune globulin (HIVIGLOB) in HIV infected pregnant Ugandan women and their infants.


METHODS
A prospective, phase I/II, three-arm dose escalation trial of HIVIGLOB.


METHODS
HIVIGLOB was prepared from discarded HIV infected units of blood collected from the National Blood Bank in Kampala. From June 1996 to April 1997, 31 HIV positive pregnant women were enrolled with HIVIGLOB infusions given at 37 weeks gestation and within 16 h of birth for infants. The first 10 mother-infant pairs were infused at a dose of 50 mg/kg, followed by 11 pairs at 200 mg/kg, and 10 pairs at 400 mg/kg. Study participants were followed for 30 months.


RESULTS
Thirty-one women and 29 infants were infused with HIVIGLOB. The infusions were safe and well tolerated by the women and their infants at all doses. There were no significant changes in virologic or immunologic parameters after HIVIGLOB infusion. Pharmacokinetic properties of this product were similar to other immune globulin products with a median half-life of 28 days in women and 30 days in infants.


CONCLUSIONS
An HIV immune globulin product derived from HIV infected Ugandan donors is safe, well tolerated, and has pharmacokinetic properties consistent with other immunoglobulin products. Data suggest that a 400 mg/kg dose of HIVIGLOB would be the most appropriate dose for a subsequent efficacy trial of HIVIGLOB for the prevention of mother to child HIV transmission.
Department of Pathology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Laura A
LA
Guay
Philippa
P
Musoke
David L
DL
Hom
Clemensia
C
Nakabiito
Danstan
D
Bagenda
Courtney V
CV
Fletcher
Lawrence H
LH
Marum
Mary Glenn
MG
Fowler
Lars G
LG
Falksveden
Britta
B
Wahren
Peter
P
Kataaha
Hans
H
Wigzell
Francis A
FA
Mmiro
J Brooks
JB
Jackson
D000328:Adult; D005260:Female; D015483:HIV Antibodies / Q000008:administration & dosage* / Q000378:metabolism; D015658:HIV Infections / Q000378:metabolism / Q000517:prevention & control*; D006207:Half-Life; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000493:pharmacokinetics; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000378:metabolism / Q000517:prevention & control*; D014454:Uganda
D015483:HIV Antibodies; D016756:Immunoglobulins, Intravenous