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Background   Defining the effect of antiretroviral regimens on breast milk HIV type-1 (HIV-1) levels is useful to inform the rational design of strategies to decrease perinatal HIV-1 transmission.Methods   Pregnant HIV-1 seropositive women (CD4 +  T-cell count &gt;250 and  2.10 log 10  copies/ml, P&lt;0.001). In contrast to breast milk HIV-1 RNA, suppression of plasma HIV-1 RNA during the neonatal period was consistently several log 10  greater in the HAART arm compared with the ZDV/NVP arm.Conclusions   HAART resulted in lower breast milk HIV-1 RNA than ZDV/NVP; however, ZDV/NVP yielded comparable breast milk HIV-1 RNA levels in the first 2 weeks post-partum. Breast milk HIV-1 RNA remained suppressed in the ZDV/NVP arm despite increased plasma HIV-1 levels, which might reflect local drug effects or compartmentalization.

Highly Active Antiretroviral Therapy versus Zidovudine/Nevirapine Effects on Early Breast Milk HIV Type-1 RNA: A Phase II Randomized Clinical Trial