Early antiretroviral therapy improves neurodevelopmental outcomes in infants.

Objectives: To evaluate the effect of early versus deferred antiretroviral therapy (ART) on the neurodevelopment of infants from Cape Town participating in the Children with HIV Early Antiretroviral Therapy (CHER) trial.

Design: HIV-infected infants were randomized to early (<3 months) or deferred ART. HIV-uninfected infants (HIV-exposed and HIV-unexposed) provide background data.

Methods: Neurological examination and Griffiths Mental Development Scales (GMDS) were administered between 10-16 months of age by testers blind to HIV status and randomized allocation. Mean quotients were compared using paired Student's t-tests.

Results: Sixty-four infants on early ART and 26 on deferred ART (of potential 77 and 38 respectively on CHER trial) were assessed at median age 11 months (range 10-16). On the GMDS, all scores were lower in the deferred arm and the General Griffiths and Locomotor Scores were significantly lower: mean (SD) =100.1 (13.8) vs. 106.3 (10.6) P=0.02; and 88.9 (16.3) vs. 97.7 (12.5), P<0.01, respectively. Children with HIV who received early ART performed as well as children without HIV except on the Locomotor subscale. Both infected and uninfected mean GMDS scores were within the average range.

Conclusion: Infants initiated on early ART have significantly better Locomotor and general scores on the GMDS at median age 11 months compared to infants on deferred ART, despite careful monitoring and ready access to ART in the latter.