Objective Clinical outcomes of HIV-infected children on antiretroviral treatment (ART) in a decentralised, nurse/counsellor-led programme.

Design Clinical cohort.

Setting KwaZulu-Natal, South Africa.

Patients HIV-infected children aged ≤15 years on ART, June 2004–2008.

Main outcome measures Survival according to baseline characteristics including age, WHO clinical stage, haemoglobin and CD4%, was assessed in Kaplan–Meier analyses. Hazard ratios for mortality were estimated using Cox proportional hazards regression and changes in laboratory parameters and weight-for-age z scores after 6–12 months' treatment were calculated.

Results 477 HIV-infected children began ART at a median age of 74 months (range 4–180), median CD4 count (CD4%) of 433 cells/mm³ (17%) and median HIV viral load of log 4.2 copies/ml; 105 (22%) were on treatment for tuberculosis and 317 (76.6%) were WHO stage 3/4. There were significant increases after ART initiation in CD4% (17% vs 22%; p<0.001), haemoglobin (9.9 vs 11.7 g/l; p≤0.001) and albumin (30 vs 36 g/l; p≤0.001). 32 (6.7%) children died over 732 child-years of follow-up (43.7 deaths/1000 child-years; 95% CI 32.7 to 58.2), 17 (53.1%) within 90 days of treatment initiation; median age of death was 84 (IQR 10–181) months. Children with baseline haemoglobin ≤8 g/l were more likely to die (adjusted HR 4.5; 95% CI 1.6 to 12.3), as were those aged <18 months compared with >60 months (adjusted HR 3.2; 95% CI 1.2 to 9.1).

Conclusions Good clinical outcomes in HIV-infected children on ART are possible in a rural, decentralised service. Few young children are on ART, highlighting the urgent need to identify HIV-exposed infants.