TY - JOUR
T1 - Phase I/II trial of HIV-1 hyperimmune globulin for the prevention of HIV-1 vertical transmission in Uganda
AU - Guay, Laura A.
AU - Musoke, Philippa
AU - Hom, David L.
AU - Nakabiito, Clemensia
AU - Bagenda, Danstan
AU - Fletcher, Courtney V.
AU - Marum, Lawrence H.
AU - Fowler, Mary Glenn
AU - Falksveden, Lars G.
AU - Wahren, Britta
AU - Kataaha, Peter
AU - Wigzell, Hans
AU - Mmiro, Francis A.
AU - Brooks Jackson, J.
PY - 2002/7/5
Y1 - 2002/7/5
N2 - Objectives: 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. Design: 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. Conclusion: 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.
AB - Objectives: 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. Design: 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. Conclusion: 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.
KW - Africa
KW - HIV hyperimmune globulin
KW - HIV vertical transmission
KW - Mother to child transmission
KW - Uganda
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U2 - 10.1097/00002030-200207050-00011
DO - 10.1097/00002030-200207050-00011
M3 - Article
C2 - 12131216
AN - SCOPUS:0037024759
SN - 0269-9370
VL - 16
SP - 1391
EP - 1400
JO - AIDS
JF - AIDS
IS - 10
ER -