TY - JOUR
T1 - A comparison of stavudine, didanosine and indinavir with zidovudine, lamivudine and indinavir for the initial treatment of HIV-1 infected individuals
T2 - Selection of thymidine analog regimen therapy (Start II)
AU - Eron, Joseph J.
AU - Murphy, Robert L.
AU - Peterson, Dolores
AU - Pottage, John
AU - Parenti, David M.
AU - Jemsek, Joseph
AU - Swindells, Susan
AU - Sepulveda, Gladys
AU - Bellos, Nicholaos
AU - Rashbaum, Bruce C.
AU - Esinhart, Jim
AU - Schoellkopf, Nancy
AU - Grosso, Robert
AU - Stevens, Michael
PY - 2000
Y1 - 2000
N2 - Objective: Comparison of stavudine (d4T), didanosine (ddl) and indinavir (IDV) with zidovudine (ZDV), lamivudine (3TC) and IDV in HIV-1 infected patients. Design: Randomized, open-label. Setting: Fourteen HIV Clinical Research Centers. Patients: Two-hundred and five patients with less than 4 weeks antiretroviral treatment, naive to 3TC and protease inhibitors and with CD4 cell counts ≥ 200 x 10 6/l and plasma HIV-1 RNA levels ≥ 10 000 copies/ml. Interventions: Stavudine 40 mg and ddl 200 mg twice daily plus IDV 800 mg every 8 h compared with ZDV 200 mg every 8 h or 300 mg twice daily, 3TC 150 mg twice daily plus IDV. Main outcome measures: The proportion of patients with plasma HIV-1 RNA levels < 500 copies/ml and ≤ 50 copies/ml and changes in CD4 cell counts were compared. Results: In an analysis of the primary endpoint, 61% of patients on d4T + ddl + IDV and 45% of patients on ZDV+ 3TC + IDV had all HIV-1 RNA values obtained between weeks 40 and 48 < 500 copies/ml [95% confidence interval (Cl) for the difference between proportions, 1.7-30.3%; P = 0.038]. In an intent-to-treat analysis, the percentage of all patients randomized with all HIV-1 RNA levels < 500 copies/ml between 40 and 48 weeks were 53% for the d4T + ddl + IDV arm and 41% for the ZDV + 3TC + IDV arm (95% Cl, -1.4% to 25.7%; P = 0.068). At 48 weeks 41% and 35% were ≤ 50 copies/ml for the stavudine- and ZDV-containing arms respectively (P > 0.2). The median time-weighted average increases in CD4 cells count over 48 weeks were 150 x 10 6/l cells for the d4T arm and 106 x 10 6/l cells for the ZDV arm (P = 0.001). The occurrence of serious adverse events was not significantly different between arms. Conclusion: The combination of stavudine, ddl and IDV resulted in potent antiretroviral effects over a 48-week period, comparable or superior to zidovudine, 3TC and IDV supporting the use of stavudine, ddl and a protease inhibitor as an initial antiretroviral treatment. (C) 2000 Lippincott Williams and Wilkins.
AB - Objective: Comparison of stavudine (d4T), didanosine (ddl) and indinavir (IDV) with zidovudine (ZDV), lamivudine (3TC) and IDV in HIV-1 infected patients. Design: Randomized, open-label. Setting: Fourteen HIV Clinical Research Centers. Patients: Two-hundred and five patients with less than 4 weeks antiretroviral treatment, naive to 3TC and protease inhibitors and with CD4 cell counts ≥ 200 x 10 6/l and plasma HIV-1 RNA levels ≥ 10 000 copies/ml. Interventions: Stavudine 40 mg and ddl 200 mg twice daily plus IDV 800 mg every 8 h compared with ZDV 200 mg every 8 h or 300 mg twice daily, 3TC 150 mg twice daily plus IDV. Main outcome measures: The proportion of patients with plasma HIV-1 RNA levels < 500 copies/ml and ≤ 50 copies/ml and changes in CD4 cell counts were compared. Results: In an analysis of the primary endpoint, 61% of patients on d4T + ddl + IDV and 45% of patients on ZDV+ 3TC + IDV had all HIV-1 RNA values obtained between weeks 40 and 48 < 500 copies/ml [95% confidence interval (Cl) for the difference between proportions, 1.7-30.3%; P = 0.038]. In an intent-to-treat analysis, the percentage of all patients randomized with all HIV-1 RNA levels < 500 copies/ml between 40 and 48 weeks were 53% for the d4T + ddl + IDV arm and 41% for the ZDV + 3TC + IDV arm (95% Cl, -1.4% to 25.7%; P = 0.068). At 48 weeks 41% and 35% were ≤ 50 copies/ml for the stavudine- and ZDV-containing arms respectively (P > 0.2). The median time-weighted average increases in CD4 cells count over 48 weeks were 150 x 10 6/l cells for the d4T arm and 106 x 10 6/l cells for the ZDV arm (P = 0.001). The occurrence of serious adverse events was not significantly different between arms. Conclusion: The combination of stavudine, ddl and IDV resulted in potent antiretroviral effects over a 48-week period, comparable or superior to zidovudine, 3TC and IDV supporting the use of stavudine, ddl and a protease inhibitor as an initial antiretroviral treatment. (C) 2000 Lippincott Williams and Wilkins.
KW - Combination antiretroviral therapy
KW - Didanosine
KW - Indinavir
KW - Randomized trial
KW - Stavudine
KW - Zidovudine lamivudine
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U2 - 10.1097/00002030-200007280-00016
DO - 10.1097/00002030-200007280-00016
M3 - Article
C2 - 10983647
AN - SCOPUS:0033821270
SN - 0269-9370
VL - 14
SP - 1601
EP - 1610
JO - AIDS
JF - AIDS
IS - 11
ER -