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Comparison of dual nucleoside-analogue reverse-transcriptase inhibitor regimens with HIV-1 who have not previously been treated: the PENTA 5 randomized trial
Introduction Treatment options for children with HIV-1 are
limited. We aimed to compare activity and safety of three dualnucleoside
analogue reverse-transcriptase inhibitor (NRTI)
regimens with or without a protease inhibitor in previously
untreated children with HIV-1.
Methods In our multicentre trial, we randomly assigned
36 children to zidovudine and lamivudine, 45 to zidovudine and
abacavir, and 47 to lamivudine and abacavir. Children who
were symptomfree (n=55) were also randomly assigned to
receive nelfinavir or placebo. Children with more advanced
disease received open-label nelfinavir (73). Primary endpoints
were change in plasma HIV-1 RNA at 24 and
48 weeks for the NRTI comparison and occurrence of serious
adverse events for both randomised comparisons. Analyses
were by intention to treat.
Findings Children had a median CD4 percentage of 22% (IQR
15–29) and a mean HIV-1 RNA concentration of 5·0 log
copies/mL (SD 0·8). One child was lost to follow-up and
one died of sepsis. At 48 weeks, in the zidovudine/lamivudine,
zidovudine/abacavir, and lamivudine/abacavir groups, mean
HIV-1 RNA had decreased by 1·71, 2·19, and 2·63 log
copies/mL, respectively (estimated in absence of nelfinavir)
(p=0·02 after adjustment for baseline factors). One child had a
hypersensitivity reaction to abacavir; and three with possible
reactions stopped abacavir. There were 24 serious adverse
events—six in the symptom-free children (all on nelfinavir), but
none were attributed to nelfinavir.
Interpretation Regimens containing abacavir were more
effective than zidovudine/lamivudine. Such regimens could be
combined with protease inhibitors and non-nucleoside reverse
transcriptase inhibitors for safe and effective treatment of
previously untreated children with HIV-1