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.

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

J Infect Dis. 1999 Mar;179(3):567-75. Unique Identifier : AIDSLINE MED/99137791
Stiehm ER; Lambert JS; Mofenson LM; Bethel J; Whitehouse J; Nugent R; Moye J Jr; Glenn Fowler M; Mathieson BJ; Reichelderfer P; Nemo GJ; Korelitz J; Meyer WA 3rd; Sapan CV; Jimenez E; Gandia J; Scott G; O'Sullivan MJ; Kovacs A; Stek A; Shearer WT; Hammill H; Department of Pediatrics, University of California at Los Angeles; Medical Center, Los Angeles, CA 90095-1752, USA.; estiehm@pediatrics.medsch.ucla.edu

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/microL (22% had counts <200/microL) 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/microL) 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.

Keywords: CLINICAL TRIAL CLINICAL TRIAL, PHASE III JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL Adult Anti-HIV Agents/*THERAPEUTIC USE Birth Weight Cesarean Section Delivery Disease Transmission, Vertical/*PREVENTION & CONTROL Female Gestational Age Human HIV Antibodies/*THERAPEUTIC USE HIV Infections/*PREVENTION & CONTROL/THERAPY/TRANSMISSION Immunoglobulins, Intravenous/*THERAPEUTIC USE Infant, Newborn Infant, Premature Pregnancy *Pregnancy Complications, Infectious Pregnancy Outcome Puerto Rico Support, U.S. Gov't, P.H.S. United States Zidovudine/*THERAPEUTIC USE
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