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.
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.
Authors: Carolyne Onyango-Makumbi; Saad B Omer; Michael Mubiru; Lawrence H Moulton; Clemensia Nakabiito; Philippa Musoke; Francis Mmiro; Sheryl Zwerski; Hans Wigzell; Lars Falksveden; Britta Wahren; Gretchen Antelman; Mary Glenn Fowler; Laura Guay; J Brooks Jackson Journal: J Acquir Immune Defic Syndr Date: 2011-12-01 Impact factor: 3.731
Authors: Veronica Tjomsland; Rada Ellegård; Karlhans Che; Jorma Hinkula; Jeffrey D Lifson; Marie Larsson Journal: PLoS One Date: 2011-08-11 Impact factor: 3.240
Authors: Cecilia Svanberg; Rada Ellegård; Elisa Crisci; Mohammad Khalid; Ninnie Borendal Wodlin; Maria Svenvik; Sofia Nyström; Kenzie Birse; Adam Burgener; Esaki M Shankar; Marie Larsson Journal: Front Immunol Date: 2021-05-20 Impact factor: 7.561
Authors: Elly Baan; Anthony de Ronde; Martijn Stax; Rogier W Sanders; Stanley Luchters; Joseph Vyankandondera; Joep M Lange; Georgios Pollakis; William A Paxton Journal: PLoS One Date: 2013-07-17 Impact factor: 3.240