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11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Antiretroviral activity and safety of indinavir (IDV) alone and in combination with zidovudine (ZDV) in ZDV-naive patients with CD4 cell counts of 50-250 cells/mm³.

Int Conf AIDS 1996 Jul 7-12; 11:25 (abstract no. LB.B.6017)
Suleiman J, Lewi D, Uip D, Pedro R, Suleiman G, Accetturi C, Lima AL, Abreu W, Levi G, Teixeira P, Alencar R, Moraes-Filho JJ, Motti E, Pecoraro ML, Makurath M, Nessly M, Leavitt R; MSD Brazil, Sao Paulo, SP, Brazil. Fax: 55-11-212-6512.

OBJECTIVES: To compare the activity and safety of IDV 800 mg q8h vs. ZDV 200 mg q8h vs. IDV+ZDV in ZDV- and protease inhibitor-naive patients with CD4 cell counts between 50 and 250 cells/mm³.

METHODS: A prospectively planned preliminary analysis was done on the first 224 patients to be randomized in an ongoing double-blind clinical endpoint trial of IDV vs IDV+ZDV vs. ZDV. Antiretroviral activity was assessed by evaluating changes in serum viral RNA (vRNA) and CD4 cell counts (CD4) during 24 weeks of therapy.

RESULTS: Mean entry CD4 was 145 cells/mm³; mean entry vRNA was 25,330 copies/mL. The mean increases in CD4 (cells/mm³) at 24 weeks were: 125, 121 and 16 for the IDV, IDV+ZDV and ZDV groups, respectively. The mean decreases in vRNA (log 10 copies/mL) at 24 weeks were -0.86, -1.09 and -0.27 for the IDV, IDV+ZDV and ZDV groups respectively. The average changes over 24 weeks, as determined by the area under the curve minus the baseline summary measure, in CD4 and vRNA were statistically significantly greater for the IDV containing groups than that for the ZDV group (p is less than 0.001). Statistically significant differences in average changes in CD4 and vRNA between the IDV and IDV+ZDV groups could not be detected. The proportion of patients with vRNA levels below the assay limit of detection (less than 500 copies/mL) at 24 weeks was 37% for IDV, 36% for IDV+ZDV and 7% for ZDV. IDV was generally well tolerated alone or in combination with ZDV; GI intolerance was more common in the IDV+ZDV group. Nephrolithiasis occurred in 1.1% of patients, and was associated with IDV therapy. Adverse experiences were generally of mild intensity and generally did not lead to discontinuation of therapy.

CONCLUSIONS: IDV was generally well tolerated and resulted in persistent elevations of CD4 and sustained suppression of vRNA through 24 weeks in most patients. The average changes from baseline over 24 weeks in surrogate markers were statistically significantly greater for the IDV containing groups than for the ZDV group.

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LBB6017