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document
Lamivudine 300 mg QD versus continued lamivudine 150 mg BID with stavudine and a protease inhibitor in suppressed patients . PURPOSE To compare the efficacy ( sustained virologic suppression ) and safety/tolerability of a switch to lamivudine 300 mg once daily ( QD ) versus continued lamivudine 150 mg twice daily ( BID ) in virologically suppressed patients ( HIV-1 RNA < 400 copies/mL for > or =3 months ) on stable ( > or =6 months ) therapy with lamivudine 150 mg BID plus stavudine and either indinavir or nelfinavir . METHOD Eighty-nine suppressed patients > or =18 years old with CD4 counts > 50 cells/mm ( 3 ) were enrolled in this phase II , open-label , multicenter , randomized , stratified ( by pretrial protease inhibitor [ PI ] ) , parallel-group clinical trial . Eighty-one patients received either lamivudine 300 mg QD ( n = 39 ) or 150 mg BID ( n = 42 ) with their pretrial stavudine/PI regimens for 24 weeks . RESULTS A high rate of virologic suppression was sustained with both regimens throughout the trial . At week 24 , intent-to-treat : exposed ( missing = failure ) analyses showed no statistically significant differences in the percentage of patients with HIV-1 RNA < 400 copies/mL ( 95 % [ QD ] vs. 90 % [ BID ] ) or < 50 copies/mL ( 82 % [ QD ] vs. 81 % [ BID ] ) or in the median change from baseline in CD4 counts ( +42 cells/mm ( 3 ) [ QD ] vs. +22 cells/mm ( 3 ) [ BID ] ) . Both regimens were well tolerated . No patient experienced virologic failure , clinical disease progression , or a drug-related serious adverse event during the trial . Self-reported medication adherence was high in both groups . CONCLUSION Patients who experience virologic suppression with a regimen of lamivudine 150 mg BID in combination with stavudine/PI can maintain that suppression by continuing their regimen or switching to lamivudine 300 mg QD and continuing the other components . Adverse event profiles were comparable among treatment regimens , and no new safety concerns were raised .
10963
Intervention_Pharmacological
Lamivudine
10964
Intervention_Pharmacological
lamivudine
10965
Intervention_Pharmacological
stavudine
10966
Intervention_Pharmacological
protease inhibitor
10967
Intervention_Pharmacological
lamivudine
10968
Intervention_Pharmacological
lamivudine
10969
Intervention_Pharmacological
lamivudine 150 mg BID plus stavudine and either indinavir or nelfinavir
10970
Intervention_Pharmacological
pretrial protease inhibitor
10971
Intervention_Pharmacological
lamivudine
10972
Intervention_Pharmacological
pretrial stavudine/PI regimens
10973
Intervention_Pharmacological
lamivudine
10974
Intervention_Pharmacological
combination with stavudine/PI
10975
Intervention_Pharmacological
lamivudine
10976
Outcome_Physical
rate of virologic suppression
10977
Outcome_Physical
percentage of patients with HIV-1 RNA
10978
Outcome_Physical
CD4 counts
10979
Outcome_Physical
virologic failure , clinical disease progression
10980
Outcome_Adverse-effects
drug-related serious adverse event
10981
Outcome_Mental
Self-reported medication adherence
10982
Outcome_Physical
virologic suppression
10983
Outcome_Physical
suppression
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Participant_Condition
suppressed
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Participant_Condition
virologically suppressed
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Participant_Condition
suppressed
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Participant_Condition
CD4 counts > 50 cells/mm ( 3 )
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Participant_Condition
virologic suppression