5th Conference on Retroviruses and Opportunistic Infections


Chicago, IL - February 1-5, 1998



A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF LAMIVUDINE (3TC) IN COMBINATION WITH ZIDOVUDINE (ZDV), STAVUDINE (d4T), OR DIDANOSINE (ddI) IN TREATMENT NAÏVE PATIENTS

Conf Retroviruses Opportunistic Infect 1998 Feb 1-5; 5th:79 (abstract no. 1)

Kuritzkes DR, Marschner IC, Johnson VA, Bassett RL, Eron JJ, Fischl MA, Boone G, Skovronski J, Wood K, Bell DL, Pettinelli CB, Sommadossi JP
University of Colorado Health Science Center, Denver, CO.

299 antiretroviral-naïve subjects with HIV-1 infection and CD4 counts of 200-600 cells/mm3 were randomized to either a d4T or ddI limb and then randomized in a blinded fashion to one of three arms within each limb (d4T limb: d4T alone, d4T/3TC, or ZDV/3TC; ddI limb: ddI alone, ddI/3TC, or ZDV/3TC). At week 24, subjects assigned to monotherapy added 3TC in a blinded manner. Entry HIV-1 RNA (bDNA) = 4.01 log10 (d4T limb) and 4.05 log10 (ddI limb) and entry CD4 count = 407 cells/mm3 and 391 cells/mm3, respectively. In the d4T limb, at 24 weeks, mean log10 change in HIV-1 RNA was -0.49, -1.03, and -0.81 for d4T, d4T/3TC, and ZDV/3TC respectively (p=0.001, d4T vs d4T/3TC; p=0.14, d4T/3TC vs ZDV/3TC). Mean change in CD4 count was +63, +104, and +76 cells/mm3, respectively (p=NS). In the ddI limb, mean log10 change in HIV-1 RNA was -0.68, -0.82, and -0.80 for ddI, ddI/3TC, and ZDV/3TC, respectively (p=NS for ddI vs ddI/3TC or for ddI/3TC vs ZDV/3TC). Mean change in CD4 count was +77, +110, and +86 cells/mm3, respectively (p=NS). Treatment was well-tolerated in all arms. The 24 week results suggest that in this patient population the combination of 3TC and MT is at least as active as the combination of 3TC and ZDV, and that the addition of 3TC to ddI does not significantly increase virologic activity compared to ddI alone. Results of the 48-week analysis will be presented.

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1998-02-01
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