Efficacy of zidovudine and human immunodeficiency virus (HIV) hyperimmune immunoglobulin for reducing perinatal HIV transmission from HIV- infected women with advanced disease: Results of pediatric AIDS clinical trials group protocol 185

E. Richard Stiehm, John S. Lambert, Lynne M. Mofenson, James Bethel, Jean Whitehouse, Robert Nugent, Moye John, Mary Glenn Fowler, Bonnie J. Mathieson, Patricia Reichelderfer, George J. Nemo, James Korelitz, William A. Meyer, Christine V. Sapan, Eleanor Jimenez, Jorge Gandia, Gwendolyn Scott, Mary Jo O'Sullivan, Andrea Kovacs, Alice StekWilliam T. Shearer, Hunter Hammill

Research output: Contribution to journalArticle

115 Scopus citations

Abstract

Pediatric AIDS Clinical Trials Group protocol 185 evaluated whether zidovudine combined with human immunodeficiency virus (HIV) hyperimmune immunoglobulin (HIVIG) infusions administered monthly during pregnancy and to the neonate at birth would significantly lower perinatal HIV transmission compared with treatment with zidovudine and intravenous immunoglobulin (IVIG) without HIV antibody. Subjects had baseline CD4 cell counts ≤500/ μL (22% had counts <200/μL) and required zidovudine for maternal health (24% received zidovudine before pregnancy). Transmission was associated with lower maternal baseline CD4 cell count (odds ratio, 1.58 per 100-cell decrement; P = .005; 10.0% vs. 3.6% transmission for count <200 vs. ≥200/μL) but not with time of zidovudine initiation (5.6% vs. 4.8% if started before vs. during pregnancy; P = .75). The Kaplan-Meier transmission rate for HIVIG recipients was 4.1% (95% confidence interval, 1.5%-6.7%) and for IVIG recipients was 6.0% (2.8%-9.1%) (P = .36). The unexpectedly low transmission confirmed that zidovudine prophylaxis is highly effective, even for women with advanced HIV disease and prior zidovudine therapy, although it limited the study's ability to address whether passive immunization diminishes perinatal transmission.

Original languageEnglish (US)
Pages (from-to)567-575
Number of pages9
JournalJournal of Infectious Diseases
Volume179
Issue number3
DOIs
StatePublished - Dec 1 1999

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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    Stiehm, E. R., Lambert, J. S., Mofenson, L. M., Bethel, J., Whitehouse, J., Nugent, R., John, M., Fowler, M. G., Mathieson, B. J., Reichelderfer, P., Nemo, G. J., Korelitz, J., Meyer, W. A., Sapan, C. V., Jimenez, E., Gandia, J., Scott, G., O'Sullivan, M. J., Kovacs, A., ... Hammill, H. (1999). Efficacy of zidovudine and human immunodeficiency virus (HIV) hyperimmune immunoglobulin for reducing perinatal HIV transmission from HIV- infected women with advanced disease: Results of pediatric AIDS clinical trials group protocol 185. Journal of Infectious Diseases, 179(3), 567-575. https://doi.org/10.1086/314637