Article
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
Paediatric European Network for Treatment of AIDS (PENTA)
Paediatric European
Network for Treatment of AIDS (PENTA)
Correspondence to: Dr D M Gibb, MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK. D.Gibb{at}ctu.mrc.ac.uk
Accepted 8 September 2000
A total of 195 children were randomised to zidovudine
(immediate) or matching placebo (deferred) in a multicentre double
blind trial in vertically HIV infected children with early disease (the PENTA 1 trial). Median follow up in the blinded phase was 1.9 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 years). Median time to
starting ART in the deferred group was 2.7 years; 19% of deferred
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%, and 6% respectively for immediate and 62%,
12%, 18%, and 8% for deferred groups. During the blinded phase eight
(7.8%) immediate and 12 (13.3%) deferred children developed AIDS or
died (log rank p = 0.24); overall 21 immediate and 20 deferred
children progressed. 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), most likely a result of increased use of combination ART.
Keywords: AIDS; HIV; zidovudine; PENTA; randomised; placebo-controlled
© 2001 by Archives of Disease in Childhood
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- HARVEY MARCOVITCH
Arch. Dis. Child. 2001 84: 0.[Extract] [Full Text] [PDF]
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