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Ritonavir + AZT + ddC
Abstract 285
Ritonavir, AZT, ddC, as Triple Combination in AIDS Patients.
Authors: D Mathez, P De Truchis, I Gorin, C Katlama, G Pialoux, AG Saimot, R Tubiana, JP Chauvin, P Bagnarelli, M Clementi, J Leibowitch.
Open-label ritonavir (1,200 mg per day) for 14 days followed by AZT (600 mg per day) plus ddC (2.25 mg per day) were administered to 29 antiretroviral-naive patients with advanced HIV disease for 6 months. Patients had baseline CD4 counts of between 50 and 250 cells/mm3, or a drop of 200 cells/mm3 to a level of less than 350 cells/mm3 over a recent 6 month period, or 250 to 350 cells/mm3 with symptoms.
A total of 32 antiretroviral naive patients were enrolled and 6 had discontinued during the study (2 due to hepatic toxicity of ritonavir). Results of surrogate marker activity were presented for 21 patients who tolerated treatment for at least 6 months.
Viral load levels as determined in both blood cells and plasma were reduced below the limit of assay detection in 6 and 5 patients, respectively, after 6 months. Twelve of the 21 patients had achieved 3 log (99.9%) or greater reduction in infectious cells. Mean reductions in plasma viral RNA over 6 months were also presented (see table 1A).
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*baseline viral load = 84,453 copies/ml |
Mean CD4 counts increased from 160 cells/mm3 at baseline to 314 cells/mm3 at month 6 (see table 2A).
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Month |
CD4 changes relative to (baseline #) |
Patients |
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0 |
0 (160) |
32 |
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1 |
124 (284) |
29 |
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2 |
125 (285) |
27 |
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4 |
125 (285) |
25 |
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5 |
143 (303) |
20 |
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6 |
154 (314) |
17 |
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