Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial.
2001
ContextAbacavir, a nucleoside analogue, has demonstrated suppression of human
immunodeficiency virus (HIV) replication alone and in combination therapy.
However, the role of abacavir in a triple nucleoside combination regimen has
not been evaluated against a standard protease inhibitor–containing
regimen for initial antiretroviral treatment.ObjectiveTo evaluate antiretroviral equivalence and safety of an abacavir-lamivudine-zidovudine
regimen compared with an indinavir-lamivudine-zidovudine regimen.Design and SettingA multicenter, phase 3, randomized, double-blind trial with an enrollment
period from August 1997 to June 1998, with follow-up through 48 weeks at 73
clinical research units in the United States, Canada, Australia, and Europe.PatientsFive hundred sixty-two antiretroviral-naive, HIV-infected adults with
a plasma HIV RNA level of at least 10 000 copies/mL and a CD4 cell count
of at least 100 × 106/L.InterventionsPatients were stratified by baseline HIV RNA level and randomly assigned
to receive a combination tablet containing 150 mg of lamivudine and 300 mg
of zidovudine twice daily plus either 300 mg of abacavir twice daily and indinavir
placebo or 800 mg of indinavir every 8 hours daily plus abacavir placebo.
After 16 weeks, patients with confirmed HIV RNA levels greater than 400 copies/mL
were eligible to continue receiving randomized treatment or receive open-label
therapy.Main Outcome MeasureVirologic suppression, defined as HIV RNA concentration of 400 copies/mL
or less at week 48.ResultsThe proportion of patients who met the end point of having an HIV RNA
level of 400 copies/mL or less at week 48 was equivalent in the abacavir group
(51% [133/262]) and in the indinavir group (51% [136/265]) with a treatment
difference of −0.6% (95% confidence interval [CI], −9% to 8%).
In patients with baseline HIV RNA levels greater than 100 000 copies/mL,
the proportion of patients achieving less than 50 copies/mL was greater in
the indinavir group than in the abacavir group with 45% (45/100) vs 31% (30/96)
and a treatment diference of −14% (95% CI, −27% to 0%). The 2
treatments were comparable with respect to their effects on CD4 cell count.
There was no difference between groups in the frequency of treatment-limiting
adverse events or laboratory abnormalities. One death in the abacavir group
was attributed to hypersensitivity reaction, which occurred following rechallenge
with abacavir, approximately 3 weeks after initiating study treatment.ConclusionsIn this study of antiretroviral-naive HIV-infected adults, the triple
nucleoside regimen of abacavir-lamivudine-zidovudine was equivalent to the
regimen of indinavir-lamivudine-zidovudine in achieving a plasma HIV RNA level
of less than 400 copies/mL at 48 weeks.
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