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Abstract: Problem: Data on soluble CD14 (sCD14) during pregnancy and lactation are scarce. We assessed the levels of sCD14 in plasma and breastmilk of Malawian HIV‐positive women and evaluated the possible association with morbidity and mortality in the HIV‐exposed children. Method of study: One hundred and forty‐nine mother/child pairs were studied. Women received antiretroviral therapy from 26 weeks of gestation to at least 6 months of exclusive breastfeeding. sCD14 concentrations were determined using an enzyme‐linked immunosorbent assay. Results: sCD14 levels measured at 26 weeks of pregnancy (median: 1418 ng/mL, IQR: 1086‐1757) were inversely correlated to maternal CD4+ cell count (r = −.283, P = .001) and to neonatal birthweight (r = −.233, P = .008). At 6 months, sCD14 plasma levels were significantly higher compared to baseline (1993 ng/mL, IQR: 1482‐2604, P < .001), and breastmilk sCD14 levels (7668 ng/mL, IQR: 5495‐10207) were 4‐fold higher than in plasma (although the concentrations in the two compartments were not correlated). No association was found between sCD14 levels in plasma or breastmilk and morbidity or mortality in children. Conclusion: Higher sCD14 levels in HIV‐positive women were associated with a more compromised maternal immunological status and to a lower neonatal birthweight, but not to poorer clinical outcomes in the HIV‐exposed children. [ABSTRACT FROM AUTHOR]