AIDS Treatment Update, No. 44, August 1996
Edward King
The CAESAR trial, also known as NUCB3007, was described in detail in AIDS Treatment Update issue 26. It recruited 1892 people with CD4 counts between 25 and 250. People who were currently taking either AZT, AZT plus ddI or AZT plus ddC were randomly assigned to receive 3TC (150 mg twice daily) or a placebo in addition to their existing therapy. The trial also enrolled some people who had not previously taken anti-HIV drugs; they were all given AZT plus 3TC. A proportion of people were assigned to add both 3TC and another anti-HIV drug, loviride, to their current treatment.
Adding 3TC (with or without loviride) did not cause any increase in side-effects, but over about a year of follow-up it was associated with a 54% reduction (from 14% to 7%) in the risk of disease progression or death compared with people who remained on their current treatment alone, which in most cases was AZT monotherapy. The benefits of adding 3TC (with or without loviride) were seen in people who were already taking combinations of AZT plus ddI or ddC, as well as those who were only taking AZT alone. The study was not large enough to detect any difference between people who added just 3TC and people who added both 3TC and loviride.
These results provide further evidence of the effectiveness of combination therapy, and suggest that anyone who is currently taking anti-HIV drugs might benefit from adding 3TC to their regimen, without additional side-effects. However, many researchers feel that adding a single new drug to an existing regimen is likely to be the least effective way of maximising its effects, and argue that changes in treatment should always consist of at least two new drugs (see pages 6-7).
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