AIDS TREATMENT NEWS No. 114 - November 4, 1990
John S. James
The average T-helper count of the volunteers beginning the treatment was 141.4. The average after treatment was 131.8; the difference was not statistically significant (meaning that the difference was small enough that it could easily have been due to chance). Statistical analysis also showed no difference in response between those who started with T-helper counts under 200, compared to those starting with higher counts.
While T-helper counts declined in most study participants, 25 percent had rises of greater than 10 percent in their baseline values. (Note: such rises can be caused by laboratory errors, and/or by the variable course of HIV infection. They do not necessarily mean that these patients benefited from the treatment.) P24 antigen was lower at weeks two and four than at baseline, but higher than baseline at weeks six and eight; neither result was statistically significant.
Comment
While this study cannot conclusively disprove the treatment -- to do that would be almost impossible -- it provides practical information that people need now. Supporters of Kemron can argue that there are different kinds of alpha interferon, and the medicine used by these study volunteers was not identical to that used in Kenya. Also, the doses could not be tightly controlled. And this was not a randomized trial, so there could be unknown biases due to self-selection by the volunteers who entered the study.
We find little practical weight in these arguments. There is no reason to believe that the small differences between various versions of alpha interferon could make the difference between a valuable treatment and no effect at all. As for dosage, if it was not controlled then it would have varied over a range which presumably would have included the effective dose in some volunteers; therefore, if the treatment worked at any dose, at least some average effect should have been seen. And it makes little sense to discount this study as not being a randomized controlled trial, since having a placebo or other control group would not have made the drug work any better than it did. People need practical answers quickly, not perfect answers in future years.
We commend SEARCH Alliance for its effectiveness in quickly organizing this study. The group announced its existence only five months ago. It has finished a useful study before most research organizations could have made the decision to start one.
For a copy of the data tabulation and analysis of this study, send a self-addressed stamped envelope to: SEARCH Alliance, 7461 Beverly Blvd., Suite 304, Los Angeles, CA 90036.
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