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Pediatric Neurodevelopmental Functioning After In Utero Exposure to Triple-NRTI vs. Dual-NRTI + PI ART in a Randomized Trial, Botswana.
Kacanek, Deborah; Williams, Paige L; Mayondi, Gloria; Holding, Penny; Leidner, Jean; Moabi, Kebaiphe; Tepper, Vicki; Nichols, Sharon; Makhema, Joseph; Jibril, Haruna; Madidimalo, Tebogo; Shapiro, Roger; Lockman, Shahin; Kammerer, Betsy.
Afiliação
  • Kacanek D; Department of Biostatistics, Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA.
  • Williams PL; Department of Biostatistics, Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA.
  • Mayondi G; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
  • Holding P; Identitea Consulting, Nairobi, Kenya.
  • Leidner J; Goodtables Consulting, Norman, OK.
  • Moabi K; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
  • Tepper V; Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.
  • Nichols S; Department of Neurosciences, University of California San Diego, San Diego, CA.
  • Makhema J; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
  • Jibril H; Botswana Ministry of Health and Wellness, Gaborone, Botswana.
  • Madidimalo T; Botswana Ministry of Health and Wellness, Gaborone, Botswana.
  • Shapiro R; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
  • Lockman S; Beth Israel Deaconess Medical Center, Boston, MA.
  • Kammerer B; Department of Immunology and Infectious Diseases, Harvard T. H. Chan School of Public Health, Boston, MA.
J Acquir Immune Defic Syndr ; 79(3): e93-e100, 2018 11 01.
Article em En | MEDLINE | ID: mdl-30015793
ABSTRACT

BACKGROUND:

In utero exposure to nucleoside reverse transcriptase inhibitor (NRTI)-containing antiretroviral treatment (ART) regimens may be associated with poor neurodevelopmental functioning in children of HIV-infected mothers. We investigated neurodevelopmental outcomes of HIV-exposed uninfected (HEU) children of HIV-infected women enrolled in a randomized trial of abacavir/zidovudine/lamivudine (triple-NRTI regimen) vs. lopinavir/ritonavir/zidovudine/lamivudine [dual-NRTI + protease inhibitor (PI) regimen].

SETTING:

The Mma Bana randomized trial was conducted in urban and rural sites in Botswana.

METHODS:

The Mma Bana study randomized HIV-infected pregnant women with CD4 ≥200 cells per mm to a triple-NRTI vs. dual-NRTI + PI regimen from 26- to 34-week gestation through planned weaning at 6-month postpartum. Partway through the study, neurodevelopmental assessments were added at 24 months of age, including the Developmental Milestones Checklist, the Bayley Scales of Infant and Toddler Development third edition, Ten Questions Questionnaire, and Profile of Social Emotional Development. We evaluated differences in mean scores between the 2 arms using unadjusted and adjusted linear regression.

RESULTS:

A total of 197 HEU infants (48% male) completed a neurodevelopmental assessment (101 in triple-NRTI arm and 96 in dual-NRTI + PI-exposed arm). Mean values for all neurodevelopmental outcomes were similar for children of mothers randomized to either ART regimen, with no significant differences in either unadjusted or adjusted models (estimated effect sizes ranging from -0.12 to 0.14).

CONCLUSIONS:

Neurodevelopmental outcomes in 24-month-old HEU children of HIV-infected mothers with baseline CD4 ≥200 were similar in those randomized to a dual-NRTI + PI-based vs. a triple-NRTI-based ART regimen, suggestive of lack of short-term toxicity. Monitoring of long-term toxicity and newer regimens is warranted.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações Infecciosas na Gravidez / Infecções por HIV / Desenvolvimento Infantil / Fármacos Anti-HIV / Terapia Antirretroviral de Alta Atividade / Transtornos do Neurodesenvolvimento / Troca Materno-Fetal Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Infant / Newborn / Pregnancy País/Região como assunto: Africa Idioma: En Revista: J Acquir Immune Defic Syndr Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Marrocos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações Infecciosas na Gravidez / Infecções por HIV / Desenvolvimento Infantil / Fármacos Anti-HIV / Terapia Antirretroviral de Alta Atividade / Transtornos do Neurodesenvolvimento / Troca Materno-Fetal Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Infant / Newborn / Pregnancy País/Região como assunto: Africa Idioma: En Revista: J Acquir Immune Defic Syndr Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Marrocos