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What Is An Aids Clinical Trial?

Fall 1996

A clinical trial is the study of new drugs for use in treatment of diseases. It is the first step in getting new medicine into the medical community. The trial protocol is developed first. It is a detailed plan which includes the reasons for the trial as well as the goal. Who qualifies is established by listing inclusion and exclusion criteria. Trials have three phases.

Phase I

In Phase I, experiments are done by using the blood of human subjects. The drug is tested on human cells in a laboratory. It is not administered to the participant. Phase one trials require a lot of detailed testing and therefore a lot of blood must be drawn from the person who is participating. In the first phase, scientists do tests to find out what dosages should be used. They determine the level of toxicity of a given drug, and they decide whether or not the drug is safe enough to administer to human beings.

Phase II

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Once the drug is proven to be safe, Phase II begins. Here the drug is tested for effectiveness by giving it to a group of people in the study. Then comparisons can be made from the information compiled from these individuals. Data is collected to establish how good a particular drug is working against a given disease.

Phase III

By Phase III, there is general knowledge of the safety, effectiveness and dosages required for a given medication. This phase is designed to confirm the information gathered in Phase I &II. When Phase III is complete, the findings are submitted to the Food and Drug Administration. The data is subject to an elaborate approval process. The FDA gives the final go-ahead to make the medicine available to the general public. Make sure you understand the consent form before you sign it! Talk to a treatment advocate. (An HIV/AIDS treatment information specialists). Women Alive. 1.800.554.4876.




  
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.
 

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