Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY)

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

doi:10.1097/QAI.0b013e31822f8914

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Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY)

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Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY)

Carolyne Onyango-Makumbi, Saad B Omer, Michael Mubiru, Lawrence H Moulton, Clemensia Nakabiito, Philippa Musoke, Francis Mmiro, Sheryl Zwerski, Hans Wigzell, Lars Falksveden, …

Journal of acquired immune deficiency syndromes (1999), Vol.58(4), pp.399-407

12/01/2011

DOI: 10.1097/QAI.0b013e31822f8914

PMCID: PMC3204156

PMID: 21826009

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Abstract

Background: This phase III, randomized, clinical trial compared single-dose nevirapine (sdNVP) plus HIV hyperimmune globulin (HIVIGLOB) with sdNVP alone for preventing maternal-to-child transmission of HIV. Primary objectives were to determine rates of HIV infection among infants and to assess the safety of HIVIGLOB in combination with sdNVP in HIV-infected Ugandan pregnant women and their infants. Methods: Mother-infant pairs were randomized to receive 200 mg of nevirapine to women in labor and 2 mg/kg NVP to newborns within 72 hours after birth (sdNVP arm) or to receive sdNVP plus a single intravenous 240-mL dose of HIVIGLOB given to women at 36- to 38-week gestation and a single intravenous 24-mL dose to newborns within 18 hours of birth (HIVIGLOB/sdNVP arm). Risk of HIV infection was determined using Kaplan-Meier and risk ratio estimates at birth, 2, 6, 14 weeks, 6, and 12 months of age. Results: Intent-to-treat analysis included 198 HIVIGLOB/sdNVP and 294 sdNVP mother-infant pairs. At 6 months of age, the primary endpoint, there was no statistically significant difference in HIV transmission in the HIVIGLOB/sdNVP arm vs. the sdNVP arm [18.7% vs. 15.0%; risk ratio = 1.240 (95% confidence interval: 0.833 to 1.846); P = 0.290]. Similarly, the proportion of serious adverse events in the HIVIGLOB/sdNVP and sdNVP arms, respectively, for mothers (18.9% vs. 19.3%; P = 0.91) and infants (62.6% vs. 59.5%; P = 0.51) was not significantly different. Conclusions: Giving mother-infant pairs an infusion of peripartum HIV hyperimmune globulin in addition to sdNVP for preventing maternal-to-child transmission was as safe as sdNVP alone but was no more effective than sdNVP alone in preventing HIV transmission.

Uganda

PMTCT

breastfeeding

HIV

sdNVP

HIVIGLOB

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Title: Subtitle: Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY)
Creators: Carolyne Onyango-Makumbi - Makerere University – Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda
Saad B Omer - Rollins School of Public Health, Emory University, Atlanta, GA, USA
Michael Mubiru - Makerere University – Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda
Lawrence H Moulton - Bloomberg School of Public Health, Johns Hopkins University, Baltimore MD, USA
Clemensia Nakabiito - Makerere University – Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda
Philippa Musoke - Makerere University – Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda
Francis Mmiro - Makerere University – Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda
Sheryl Zwerski - Division of AIDS, NIAID, NIH, Rockville MD, USA
Hans Wigzell - Karolinska Institute, Stockholm, Sweden
Lars Falksveden - Swedish Institute for Infectious Disease Control, Stockholm, Sweden
Britta Wahren - Swedish Institute for Infectious Disease Control, Stockholm, Sweden
Gretchen Antelman - International Center for AIDS Care and Treatment Programs, Mailman School of Public Health, Columbia University, New York, NY, USA
Mary Glenn Fowler - Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Laura Guay - George Washington University, School of Public Health and Health Services, Washington, DC, USA
J. Brooks Jackson - Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Resource Type: Journal article
Publication Details: Journal of acquired immune deficiency syndromes (1999), Vol.58(4), pp.399-407
DOI: 10.1097/QAI.0b013e31822f8914
PMID: 21826009
PMCID: PMC3204156
NLM abbreviation: J Acquir Immune Defic Syndr
ISSN: 1525-4135
eISSN: 1944-7884
Grant note: U01 AI069530-01 || AI / National Institute of Allergy and Infectious Diseases Extramural Activities : NIAID R01 AI034235-06 || AI / National Institute of Allergy and Infectious Diseases Extramural Activities : NIAID U01 AI048054-01 || AI / National Institute of Allergy and Infectious Diseases Extramural Activities : NIAID U01 AI038576-06 || AI / National Institute of Allergy and Infectious Diseases Extramural Activities : NIAID
Language: English
Date published: 12/01/2011
Academic Unit: Pathology; VPMA - Administration
Record Identifier: 9984047898402771

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Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY)

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