Background: Morbidity and mortality patterns among pregnant women and their infants (before antiretroviral therapy was widely available) determines HIV-1 diagnostic, monitoring, and care interventions.
Methods: Data from mothers and their infants enrolled in a trial of antibiotics to reduce mother-to-child-transmission of HIV-1 at 4 sub-Saharan African sites were analyzed. Women were enrolled during pregnancy and follow-up continued until the infants reached 12 months of age. We describe maternal and infant morbidity and mortality in a cohort of HIV-1-infected and HIV-1-uninfected mothers. Maternal and infant factors associated with mortality risk in the infants were assessed using Cox proportional hazard modeling.
Results: Among 2292 HIV-1-infected mothers, 166 (7.2%) had a serious adverse event (SAE) and 42 (1.8%) died, whereas no deaths occurred among the 331 HIV-1 uninfected mothers. Four hundred twenty-four (17.8%) of 2383 infants had an SAE and 349 (16.4%) died before the end of follow-up. Infants with early HIV-1 infection (birth to 4–6 weeks) had the highest mortality. Among infants born to HIV-1-infected women, maternal morbidity and mortality (P = 0.0001), baseline CD4 count (P = 0.0002), and baseline plasma HIV-1 RNA concentration (P < 0.0001) were significant predictors of infant mortality in multivariate analyses.
Conclusions: The high mortality among infants with early HIV-1 infection supports access to HIV-1 diagnostics and appropriate early treatment for all infants of HIV-1-infected mothers. The significant association between stage of maternal HIV-1 infection and infant mortality supports routine CD4 counts at the time of prenatal HIV-1 testing.
From the *University of North Carolina Project, Lilongwe, Malawi; †Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA; ‡University of North Carolina School of Public Health, University of North Carolina and §Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC; ∥Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; ¶Family Health International, Research Triangle Park, NC; #Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; **Department of Obstetrics and Gynecology, University of Alabama, Birmingham, AL; ††Department of Obstetrics and Gynaecology, College of Medicine, University of Malawi, Blantyre, Malawi; ‡‡Muhimbili University, Dar-Es Salaam, Tanzania; §§Pediatric, Adolescent, and Maternal AIDS Branch, National Institute of Child Health and Human Development; and ∥∥Department of Biostatistics, University of Washington, Seattle, WA.
Accepted for publication February 27, 2008.
This study was supported by the HIV Network for Prevention Trials (HIVNET) and sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health, and Department of Health and Human Services, through contract #N01-AI-35173 with Family Health International; contract #N01-AI-45200 with Fred Hutchinson Cancer Research Center; and subcontract #N01-AI-35173-117/412 with Johns Hopkins University. This work was also sponsored by the U.S. National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute of Mental Health, and the Office of AIDS Research at the National Institutes of Health, U.S. Department of Health and Human Services, Harvard University (U01-AI-48006), Johns Hopkins University (U01-AI-48005), and the University of Alabama at Birmingham (U01-AI-47972). Nevirapine (Viramune, Boehringer Ingelheim GmbH, Ingelheim, Germany) for the study provided by Boehringer Ingelheim Pharmaceuticals, Incorporated.
Address for correspondence: Irving Hoffman, PA, MPH, Division of Infectious Diseases, University of North Carolina at Chapel Hill, 130 Mason Farm Rd. Chapel Hill, North Carolina 27599. E-mail: email@example.com.