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Two studies compare triple nucleoside therapy Ziagen® + Combivir® with protease inhibitorplus Combivir® regimens in therapy-naive patients

Preliminary data on triple nucleoside regimen compared to PI-containing regimen presented in Durban, South Africa.

Patients reported on their adherence to the regimens.

Durban, South Africa -- July 12, 2000 -- Two studies comparing the triple nucleoside regimen of Ziagen® (abacavir sulfate) plus Combivir® (lamivudine/zidovudine) with triple-drug regimens containing protease inhibitors (PI) as first-line antiretroviral therapy (ART) were presented here today at the 13th International AIDS Conference in Durban, South Africa.

Preliminary 24-week data from two open-label randomized trials assess Ziagen/Combivir as first line ART. Further, one study evaluated adherence to Ziagen/Combivir compared to the PI-containing regimen.

The Ziagen/Combivir regimen consisted of taking one Ziagen tablet and one Combivir tablet twice a day without dietary restriction. Patients on the nucleoside plus PI regimen took two indinavir tablets every eight hours and one Combivir tablet twice a day in one study and three nelfinavir tablets every eight hours and one Combivir tablet twice a day in the second study. The patients taking indinavir were required to take the tablets 1 hour before or 2 hours after a meal and drink one-and-a-half quarts of water a day.

"We are pleased to have these additional, preliminary data that compare the Ziagen plus Combivir regimen of just two tablets twice a day to a protease-containing regimen," said Lynn Smiley, M.D., vice president, HIV and Opportunistic Infections Clinical Development at Glaxo Wellcome.

Ziagen/Combivir vs Indinavir/Combivir

In this open-label multi-center study (CNAB3014) of 342 antiretroviral therapy-naive patients, patients were randomized to receive Ziagen/Combivir or indinavir/Combivir for 48 weeks. Patients were stratified according to baseline plasma viral load (VL), with 63 percent having a VL greater than 5,000 copies/ml but less than 100,000 copies/ml, and 3
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Contact: Beth Schlesinger
bschlesinger@pcipr.com
312-558-1770
Public Communications Inc.
12-Jul-2000


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