Objectives: To describe 5-year growth, survival, and long-term safety among children exposed to nevirapine or zidovudine in an African perinatal prevention trial, HIVNET 012.
Methods: All study children who were alive at the age 18 months were eligible for an extended follow-up study. Children whose families consented were enrolled and evaluated every 6 months from 24 to 60 months. At each visit, history, physical examination, and growth measures were taken. From these measurements, Z scores based on World Health Organization (WHO) standards were computed. Serious adverse event data were collected. Data from the initial and extended follow-up cohorts were included in the analysis.
Results: Five hundred twenty-eight study children were alive at the age 18 months, and 491 (426 HIV uninfected and 65 infected) were enrolled into the follow-up study. Both exposed but uninfected children and HIV-infected children were substantially below WHO growth standards for weight and height. Head circumference Z scores for uninfected children were comparable with WHO norms. Five-year survival rates were 93% for uninfected children versus 43% for infected children. Long-term safety and growth outcomes in the 2 study arms were similar.
Conclusions: Both infected and uninfected children in the 5-year HIVNET 012 follow-up showed poor height and weight growth outcomes, underscoring the need for early nutritional interventions to improve long-term growth of all infants born to HIV-infected women in resource-limited settings. Similarly, the low 5-year survival among HIV-infected children support the importance of early initiation of antiretroviral therapy. Both peripartum nevirapine and zidovudine were safe.
*Clinical Division, Makerere University—Johns Hopkins University Research Collaboration, Kampala, Uganda;
†Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA;
‡Department of Pediatrics and Child Health, Makerere University, Kampala, Uganda;
§Science Facilitation Department, Family Health International, Durham, NC;
‖Department of Pathology, Johns Hopkins University, Baltimore, MD; and
¶Department of Epidemiology and Biostatistics, George Washington University School of Public Health and Health Services, Washington, DC.
Correspondence to: Maxensia Owor, MBChB, Makerere University—Johns Hopkins University Research Collaboration, P.O. Box 23491, Kampala, Uganda (e-mail: email@example.com).
Supported by (1) the HIV Network for Prevention Trials (HIVNET) and sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), through contract N01-AI-35173 with Family Health International, contract N01-AI-45200 with Fred Hutchinson Cancer Research Center, and subcontract (N01-AI-35173-417) with Johns Hopkins University; (2) the HIV Prevention Trials Network (HPTN) sponsored by the NIAID, National Institutes of Child Health and Human Development (NICH/HD), National Institute on Drug Abuse, National Institute of Mental Health, and Office of AIDS Research, of the NIH, DHHS (U01-AI-46745, U01-AI-48054, and U01-AI-068613), and the International Maternal Pediatric Adolescent AIDS Clinical Trials Group sponsored by the NIAID and NICH/HD (U01-AI-068632, U01-AI-069530).
The authors have no conflicts of interest to disclose.
F.M. is deceased.
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Received April 26, 2013
Accepted September 09, 2013