title: Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana.
abstract: Risk factors for mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) via breast-feeding were evaluated in a randomized trial. HIV-infected women and their infants received zidovudine as well as single-dose nevirapine or placebo. Infants were randomized to formula-feed (FF) or breast-feed (BF) in combination with zidovudine prophylaxis. Of 1116 at-risk infants, 6 (1.1%) in the FF group and 7 (1.3%) in the BF group were infected between birth and 1 month (P=.99). Maternal receipt of nevirapine did not predict early MTCT in the BF group (P=.45). Of 547 infants in the BF group at risk for late MTCT, 24 (4.4%) were infected. Maternal HIV-1 RNA levels in plasma (P<.001) and breast milk (P<.001) predicted late MTCT. These findings support the safety of 1 month of breast-feeding in combination with maternal and infant antiretroviral prophylaxis. Trial registration. ClinicalTrials.gov identifiers: NCT00197691 and NCT00197652.
authors.affiliation: Beth Israel Deaconess Medical Center, Division of Infectious Diseases, Boston, Massachusetts 02215, USA. rshapiro@hsph.harvard.edu
authors.forename: Roger L
authors.initials: RL
authors.lastname: Shapiro
authors.forename: Laura
authors.initials: L
authors.lastname: Smeaton
authors.forename: Shahin
authors.initials: S
authors.lastname: Lockman
authors.forename: Ibou
authors.initials: I
authors.lastname: Thior
authors.forename: Raabya
authors.initials: R
authors.lastname: Rossenkhan
authors.forename: Carolyn
authors.initials: C
authors.lastname: Wester
authors.forename: Lisa
authors.initials: L
authors.lastname: Stevens
authors.forename: Claire
authors.initials: C
authors.lastname: Moffat
authors.forename: Peter
authors.initials: P
authors.lastname: Arimi
authors.forename: Patrick
authors.initials: P
authors.lastname: Ndase
authors.forename: Aida
authors.initials: A
authors.lastname: Asmelash
authors.forename: Jean
authors.initials: J
authors.lastname: Leidner
authors.forename: Vladimir
authors.initials: V
authors.lastname: Novitsky
authors.forename: Joseph
authors.initials: J
authors.lastname: Makhema
authors.forename: Max
authors.initials: M
authors.lastname: Essex
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001902:Botswana / Q000453:epidemiology; D001942:Breast Feeding / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D008895:Milk, Human / Q000821:virology; D019829:Nevirapine / Q000627:therapeutic use; D012367:RNA, Viral / Q000032:analysis / Q000097:blood; D012307:Risk Factors; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D015215:Zidovudine; D019829:Nevirapine