ArticleAIDS (London, England)2016
Antiretroviral exposure during pregnancy and adverse outcomes in HIV-exposed uninfected infants and children using a trigger-based design.
Article in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01310023 (Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Does antiretroviral therapy cause congenital malformations? A systematic review and meta-analysis.Epidemiology and health · 2021Pooled it
- Immunologic and Virologic Factors Associated With Hospitalization in Human Immunodeficiency Virus-Exposed, Uninfected Infants in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Hearing Measures in Children Perinatally HIV-exposed and Uninfected in the PHACS SMARTT Study.The Pediatric infectious disease journal · 2026Article
- Article
- Maternal stress in pregnancy and adverse birth outcomes among women living with HIV during the COVID-19 pandemic.Frontiers in reproductive health · 2026Article
- Maternal Use of Integrase Strand Transfer Inhibitors During Pregnancy and Infant Neurodevelopment.JAMA network open · 2025Article
- Maternal HIV Infection and Antiretroviral Therapy in Pregnancy: Implications for Vertical Transmission, Fetal Safety, and Long-Term Infant Outcomes.Pathogens (Basel, Switzerland) · 2025Review
- Birth outcomes following bictegravir exposure during pregnancy.AIDS (London, England) · 2025Article
- Perinatal exposure to atazanavir-based antiretroviral regimens in a mouse model leads to differential long-term motor and cognitive deficits dependent on the NRTI backbone.Frontiers in molecular neuroscience · 2024Article
- Antiretroviral Options and Treatment Decisions During Pregnancy.Paediatric drugs · 2023Review
- In Utero Antiretroviral Exposure and Risk of Neurodevelopmental Problems in HIV-Exposed Uninfected 5-Year-Old Children.AIDS patient care and STDs · 2023Article
- In utero and peripartum antiretroviral exposure as predictor of cognition in 6- to 10-year-old HIV-exposed Ugandan children - a prospective cohort study.HIV medicine · 2021Article
- Mitochondrial DNA Instability Is Common in HIV-Exposed Uninfected Newborns.Journal of clinical medicine · 2021Article
- Elevated Blood Mitochondrial DNA in Early Life Among Uninfected Children Exposed to Human Immunodeficiency Virus and Combination Antiretroviral Therapy in utero.The Journal of infectious diseases · 2021Article
- Mitochondrial DNA Parameters in Blood of Infants Receiving Lopinavir/Ritonavir or Lamivudine Prophylaxis to Prevent Breastfeeding Transmission of HIV-1.Journal of clinical medicine · 2020Article
- Differences in Growth of HIV-exposed Uninfected Infants in Ethiopia According to Timing of In-utero Antiretroviral Therapy Exposure.The Pediatric infectious disease journal · 2020Article
- Safety of in-utero antiretroviral exposure: neurologic outcomes in children who are HIV-exposed but uninfected.AIDS (London, England) · 2020Article
- Brain microstructural changes support cognitive deficits in HIV uninfected children born to HIV infected mothers.Brain, behavior, & immunity - health · 2020Article
- Antiretroviral Prescribing Practices Among Pregnant Women Living With HIV in the United States, 2008-2017.JAMA network open · 2019Observational
- Growth and Neurodevelopment of HIV-Exposed Uninfected Children: a Conceptual Framework.Current HIV/AIDS reports · 2019Review
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
objectiveTo evaluate the safety of in-utero antiretroviral exposure in children born to mothers with HIV, using a trigger-based design.
designThe Surveillance Monitoring of ART Toxicities Study is a prospective cohort study conducted at 22 US sites to evaluate safety of in-utero antiretroviral drug exposure in HIV-uninfected children born to HIV-infected mothers. Children meeting predefined clinical or laboratory thresholds have more intensive evaluations to determine whether they meet criteria for adverse events.
methodsAdverse event "cases" were defined for the following domains: growth, hearing, language, neurology, neurodevelopment, metabolic, hematologic/clinical chemistry and blood lactate. We used adjusted log-binomial models to calculate relative risks (RR) of case status overall and within individual domains for various antiretroviral exposures during pregnancy.
resultsAmong 2680 youth enrolled between 2007 and 2012 (48% female, 66% black, 33% Hispanic), 48% met a trigger and 25% were defined as a case in at least one domain. Language (13.2%) and metabolic (11.4%) cases were most common. After adjustment for birth cohort and other factors, there was no association of any antiretroviral regimen, drug class, or individual drug with meeting overall case criteria (case in any domain). Within individual domains, zidovudine (74% exposed) was associated with increased risk of metabolic case [RR = 1.69, 95%confidence interval (CI) 1.08-2.64] and didanosine plus stavudine (<1% exposed) with increased risk of both neurodevelopmental (RR = 12.40, 95%CI 5.29-29.08) and language (RR = 4.84, 95%CI 1.14-20.51) cases.
conclusionOur findings support current recommendations for combination antiretroviral therapy during pregnancy, although higher risk of metabolic disorder with zidovudine exposure warrants further study.
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