Study Design and Population:

The EIT Study methods have been previously described.(13) In brief, from April 2015 to July 2018 we enrolled infants with HIV (≥35 weeks gestation, weight ≥2000 grams) and began ART <7 days of age. All children had initiated prophylaxis near birth with 2 or 3 antiretroviral agents, and upon study enrollment were transitioned to ART with treatment doses of NVP (6 mg/kg twice daily [BID]), ZDV (4 mg/kg BID), and 3TC (2 mg/kg BID) as the initial regimen. Per protocol, the regimen was switched to LPV/r, ZDV, and 3TC at ≥40 weeks gestational age equivalence.(20) Children were followed weekly for 6 weeks, then at 8 and 12 weeks, and 12-weekly thereafter for a minimum of 96 weeks. Clinical evaluation and HIV-1 RNA testing of all enrolled participants occurred at each visit. CD4 cell count testing, quantitative DNA PCR testing of PBMCs, complete blood count, and chemistry were performed at enrolment and longitudinally.