Journal article
Phase I/II trial of HIV-1 hyperimmune globulin for the prevention of HIV-1 vertical transmission in Uganda
AIDS (London), Vol.16(10), pp.1391-1400
2002
DOI: 10.1097/00002030-200207050-00011
PMID: 12131216
Abstract
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.
Details
- Title: Subtitle
- Phase I/II trial of HIV-1 hyperimmune globulin for the prevention of HIV-1 vertical transmission in Uganda
- Creators
- Laura A GUAY - Department of Pathology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, United StatesPhilippa MUSOKE - Department of Paediatrics, Makerere University, Kampala, UgandaPeter KATAAHA - Nakasero Blood Bank, Ministry of Health, Kampala, UgandaHans WIGZELL - Karolinska Institute, Stockholm, SwedenFrancis A MMIRO - Department of Obstetrics and Gynaecology, Makerere University, Kampala, UgandaJ. Brooks JACKSON - Department of Pathology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, United StatesDavid L HOM - Department of Medicine University of Medicine and Dentistry of New Jersey, Newark, New Jersey, United StatesClemensia NAKABIITO - Department of Obstetrics and Gynaecology, Makerere University, Kampala, UgandaDanstan BAGENDA - Department of Obstetrics and Gynaecology, Makerere University, Kampala, UgandaCourtney V FLETCHER - Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota, United StatesLawrence H MARUM - Centers for Disease Control and Prevention, Global AIDS Program, Nairobi, KenyaMary Glenn FOWLER - Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, Atlanta, Georgia, United StatesLars G FALKSVEDEN - Swedish Institute for Infectious Disease Control, Stockholm, SwedenBritta WAHREN - Swedish Institute for Infectious Disease Control, Stockholm, Sweden
- Resource Type
- Journal article
- Publication Details
- AIDS (London), Vol.16(10), pp.1391-1400
- Publisher
- Lippincott Williams & Wilkins; Hagerstown, MD
- DOI
- 10.1097/00002030-200207050-00011
- PMID
- 12131216
- ISSN
- 0269-9370
- eISSN
- 1473-5571
- Language
- English
- Date published
- 2002
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984047603802771
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