Lamivudine in combination with zidovudine, stavudine, or didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial

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Abstract
To study the antiviral activity of lamivudine (3TC) plus zidovudine (ZDV), didanosine (ddI), or stavudine (d4T). Randomized, placebo-controlled, partially double-blinded multicenter study. Adult AIDS Clinical Trials Units. Treatment-naive HIV-infected adults with 200-600¥106 CD4 T lymphocytes/l. Patients were openly randomized to a d4T or a ddI limb, then randomized in a blinded manner to receive: d4T (80mg/day), d4T plus 3TC (300mg/day), or ZDV (600mg/day) plus 3TC, with matching placebos; or ddI (400mg/day), ddI plus 3TC (300mg/day), or ZDV (600mg/day) plus 3TC, with matching placebos. After 24 weeks 3TC was added for patients assigned to the monotherapy arms. The reduction in plasma HIV-1 RNA level at weeks 24 and 48. Two hundred ninety-nine patients were enrolled. After 24 weeks the mean reduction in plasma HIV-1 RNA copies/ml from baseline was 0.49 log10 (d4T monotherapy) versus 1.03 log10 (d4T plus 3TC; P=0.001), and 0.68 log10 (ddI monotherapy) versus 0.82 log10 (ddI plus 3TC; P>0.22). After 48 weeks the mean reduction was 1.08 log10 (d4T plus 3TC) versus 1.01 log10 (ZDV plus 3TC) in the d4T limb (P=0.66), and 0.94 log10 (ddI plus 3TC) versus 0.88 log10 (ZDV plus 3TC; P=0.70) in the ddI limb. 3TC added significantly to the virologic effects of d4T, but not ddI, in treatment-naive patients. 3TC plus d4T produced virologic changes comparable to those of 3TC plus ZDV. These results support the use of 3TC with either ZDV or d4T as a component of initial combination antiretroviral therapy.

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