GMHC Treatment Issues (Newsletter of Experimental AIDS Therapies) Volume 13, Number 2 - February 1999
The Atlantic Study is a major ongoing multicenter European and North American trial directly comparing protease-containing and protease-sparing regimens. Preliminary 24-week data were presented at the 6th Conference on Retroviruses and Opportunistic Infections. Study participants receive d4T/ddI/ 3TC, d4T/ddI/ nevirapine or d4T/ddI/ indinavir in open-label fashion.
Atlantic Study: Intent-to-Treat Analysis at 24 weeks
d4T/ddI/3TC Number of currently evaluable participants = 88 Baseline Median CD4 Count = 414 Baseline Median Viral Load = 16,595 Percent with viral load below 50 copies/ ml = 56% Median increase in CD4 count = +104
d4T/ddI/nevirapine Number of currently evaluable participants = 68 Baseline Median CD4 Count = 473 Baseline Median Viral Load = 15,488 Percent with viral load below 50 copies/ml = 67% Median increase in CD4 count = +146
d4T/ddI/indinavir Number of currently evaluable participants = 78 Baseline Median CD4 Count =448 Baseline Median Viral Load = 15,153 Percent with viral load below 50 copies/ml = 71% Median increase in CD4 count = +154
At 24 weeks the nevirapine and indinavir arm look similar in their ability to raise CD4 cell counts and reduce viral load while the 3TC-containing arm appears inferior (C. Katlama et al, slide presentation 18). This difference does not reach statistical significance, however. In a related study of 12 individuals enrolled in Atlantic, researchers looked at whether initial HIV clearance rates differed by on regimen. The conclusion was that it did not (R. van Heeswijk et al., poster 634).
The criticism most often leveled at this study is that baseline viral loads were only about 15,000 in all three arms. This low level makes it difficult to compare the different treatments' potency.
Atlantic has a targeted enrollment of 300, of which 287 had entered the study by last fall. The ddI is taken once daily between meals while the d4T is taken in its usual twice-a-day schedule, as is the 3TC. The indinavir is administered three times a day, and the nevirapine is given at a 400 mg once daily dose.
So far, nevirapine-induced rashes resulted in nine switches to other arms of the study, two individuals reported severe peripheral neuropathy (probably from the d4T and ddI) and 12 individuals in the nevirapine arm reported grade 3 or 4 liver function abnormalities.- MN
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