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

J Infect Dis. 1999 Mar;179(3):567-75. doi: 10.1086/314637.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Anti-HIV Agents / therapeutic use*
  • Birth Weight
  • Cesarean Section
  • Delivery, Obstetric
  • Female
  • Gestational Age
  • HIV Antibodies / therapeutic use*
  • HIV Infections / prevention & control*
  • HIV Infections / therapy
  • HIV Infections / transmission
  • Humans
  • Immunoglobulins, Intravenous / therapeutic use*
  • Infant, Newborn
  • Infant, Premature
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Pregnancy
  • Pregnancy Complications, Infectious*
  • Pregnancy Outcome
  • Puerto Rico
  • United States
  • Zidovudine / therapeutic use*

Substances

  • Anti-HIV Agents
  • HIV Antibodies
  • HIV hyperimmune globulin
  • Immunoglobulins, Intravenous
  • Zidovudine