Effect of the timing of antiretroviral treatment initiation on CD4 count in children and youths living with HIV in North India.

Abstract

Immediate start of antiretroviral treatment (ART) among non-hospitalized outpatient children living with HIV may improve or worsen clinical outcomes due to immune reconstitution. Role of immediate versus post-stabilization start of antiretroviral treatment in children and youths living with HIV on CD4 count and viral load suppression. This was a single blinded, randomized controlled trial conducted on outpatients attending a tertiary care hospital associated HIV clinic in North India. We enrolled ART-naive children and youths living with HIV aged 18months to 21years in a 1:1 ratio. Block randomization was done using computerized software. Children and youths living with HIV were either started with ART on diagnosis immediately within 24h (Group A) or post stabilization at 2weeks (Group B) as per National AIDS Control Organization (NACO) India guidelines. Both groups were comparable for baseline characteristics. There was no significant difference seen in CD4 counts between two groups at 6months follow up. CD4 count increased significantly in immediate group but not in post-stabilization group at 6months. No significant changes/differences was seen in WHO clinical staging or anthropometry; one patient developed tuberculosis in both groups. Viral load at 6months in both the groups did not differ significantly. Immediate ART in children and youths living with HIV results in significant increase in CD4 count at 6months follow up exemplifying immunological response to ART.