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Five-year follow-up of vertically HIV-infected children in a randomised double blind controlled trial of immediate versus deferred zidovudine: the PENTA 1 trial. Archives of Diseases in Childhood (2001) 84, 3, 230-236.

Summary

195 children were randomised to ZDV (Immediate) or matching placebo (Deferred) in a multicentre double-blind trial in vertically HIV-infected children with early disease (the PENTA 1 trial). Median (IQR) follow-up in the blinded phase was 1.9 (1.3-2.7) years. Thereafter, individual children were unblinded following the results of adult trials showing a benefit of combination antiretroviral therapy (ART) over monotherapy, but follow-up continued and is reported here until December 1998 (total follow-up 4.6 (3.6-5.6 yr.).

Median (IQR) time to starting ART in the Def group was 2.7 (1.3-4.1) years and 19% of Def children had not started ART by 1999. Throughout follow-up, the percentage of time spent on no ART, monotherapy, dual and triple ART was 21%, 44%, 29%, 6% respectively for Imm and 62%, 12%, 18%, 8% for Def groups.

During the blinded phase 8 (7.8%) Imm and 12 (13.3%) Def children developed AIDS or died (log rank p=0.24) and overall 21 Imm and 20 Def children progressed (log rank p=0.80).

In an analysis including all children regardless of original allocation, the risk of progression to AIDS or death adjusting for age and time since trial entry was significantly lower during 1997-98 (2.4 per 100 child-years) than during 1992-96 (6.6 per 100 child-years, p<0.0001), most likely due to increased use of combination ART.