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document
Once-daily versus twice-daily lamivudine , in combination with zidovudine and efavirenz , for the treatment of antiretroviral-naive adults with HIV infection : a randomized equivalence trial . A randomized , double-blind , double-dummy controlled , multicenter trial was conducted that involved 554 antiretroviral-naive human immunodeficiency virus-infected adults ( plasma HIV type 1 [ HIV-1 ] RNA level , > or=400 copies/mL ; CD4 ( + ) cell count , > 100 cells/mm ( 3 ) ) and compared a 300-mg once-daily ( q.d . ) regimen of lamivudine ( 3TC ) versus a 150-mg twice-daily ( b.i.d . ) regimen of 3TC , combined with zidovudine ( 300 mg b.i.d . ) and efavirenz ( 600 mg q.d . ) , during a 48-week period . Treatments were considered equivalent if the 95 % confidence interval ( CI ) for the difference in proportions of patients achieving an HIV-1 RNA level of < 400 copies/mL was within the bound of -12 % to 12 % . At week 48 of the study , an intent-to-treat analysis in which patients with missing data were considered to have experienced treatment failure showed that the 3TC q.d . and 3TC b.i.d . regimens were equivalent ( HIV-1 RNA level < 400 copies/mL , 178 [ 64 % ] of 278 vs. 174 [ 63 % ] of 276 ; treatment difference , 1 % [ 95 % CI , -7.1 % to 8.9 % ] ; HIV-1 RNA level < 50 copies/mL , 165 [ 59 % ] of 278 vs. 168 [ 61 % ] of 276 ; treatment difference , 1.7 % [ 95 % CI , -9.7 % to 6.6 % ] ) . Median increase above baseline in CD4 ( + ) cell count was similar ( q.d . group , +144 cells/mm ( 3 ) ; b.i.d . group , +146 cells/mm ( 3 ) ) , and the incidences of adverse events , disease progression , and HIV-associated conditions were comparable .
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Intervention_Pharmacological
lamivudine , in combination with zidovudine and efavirenz
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Intervention_Pharmacological
lamivudine ( 3TC )
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Intervention_Pharmacological
3TC , combined with zidovudine ( 300 mg b.i.d . ) and efavirenz
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Intervention_Pharmacological
3TC
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Intervention_Pharmacological
3TC
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Outcome_Other
equivalence
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Outcome_Other
equivalent
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Outcome_Other
HIV-1 RNA level of < 400 copies/mL
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Outcome_Other
failure
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Outcome_Physical
Median increase above baseline in CD4 ( + ) cell count
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Outcome_Adverse-effects
incidences of adverse events , disease progression , and HIV-associated conditions
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Participant_Condition
antiretroviral-naive
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Participant_Age
adults
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Participant_Condition
HIV infection
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Participant_Sample-size
554
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Participant_Condition
human immunodeficiency virus-infected
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Participant_Age
adults