Research Hypothesis: We hypothesize that our new drug, hivaril, is more effective at raising t-cell counts in AIDs patients than traditional drug cocktails. Dependent Variables: T-cell counts Independent Variables: Drug treatment Selecting Subjects: Patients who have developed bona fide AIDs, not HIV, will be selected for this process…
Patients with extremely low T-cell counts at imminent danger of dying will not be excluded but will be given special treatment as noted below in the discussion of ethical concerns. Study Design: Patients will be split into three groups: A placebo control group, a standard cocktail control group and a hivaril experimental group. For the hivaril group, in order to mask that a newer drug is being provided, the rest of the cocktail elements will be simulated by identical-looking placebos. Patients will be monitored for six months regularly to check T-cell performance and other vectors of improved health, as well as to see for toxicity. Statistical Model: Our intent is to see, at a very high confidence level with a moderate margin of error (+/- 3% would be acceptable), if hivaril is comparable to or superior to both the cocktail control group and the placebo control group. The hypothesis is directional, with the null hypothesis being that hivaril is worse than the cocktail and identical to a placebo. The drug would still be a major improvement if it were better than the placebo but slightly worse than the cocktail. The alternative hypothesis is as noted. Because three groups are being measured, and must be to preserve a placebo control, ANOVA will be used. Luckily, the sample size is large enough that no other modification is needed. ...
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