(ATN) Ampligen: Study Stopped After Poor Results

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(ATN) Ampligen: Study Stopped After Poor Results

AIDS TREATMENT NEWS No. 067 - October 21, 1988
John S. James


An article in The New York Times October 14 confirmed rumors that had been circulating for weeks -- that ampligen was not proving effective in the current double-blind trials.

After 20 patients in that study progressed to AIDS, the code was broken for those 20. Twelve of them were taking ampligen, compared to eight who were taking the placebo -- indicating that ampligen was not stopping the progression to AIDS.

According to a phone call from one patient in the study, a higher-dose arm of the trial might still be continued.

Ampligen had been considered a very promising treatment after an earlier study, published in June 1987, reported good results in 10 patients with AIDS, ARC, or lymphadenopathy -- especially reductions in viral cultures or other measures of viral activity. That study did not have enough patients to look for prevention of progression to AIDS.

Apparently no one knows why the two studies of the same drug produced such different results. Finding out why might help prevent similar errors in the future.


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