Long-Term Follow-Up of Children in the HIVNET 012 Perinatal HIV Prevention Trial
Year: 2013
Type: article
Abstract: 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.
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: STATISTICAL &CLINICAL COORDINATING CENTER (SC), G2358511323, G4077209806, HPTN - CENTRAL LABORATORY, Makerere Univ.-Johns Hopkins Univ. HIV Clinical Trials Unit-Kampala, Uganda, INTNL.VACC.EFFICACY TRIALS MASTER CONTRACT (IMC), International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group, HIV Prevention Trials Network: Network Laboratory, MU-JHU HPTU TRIAL SITE - UGANDA, SDMC: HIV Prevention Trials Network, G982464176
OpenAlex ID: W2040978835
