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10021 - HIV Clinical Trials Janice Price M.Ed RN HIV...

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HIV Clinical Trials Janice Price, M.Ed, RN HIV Clinical Research Program Coordinator Swedish Medical Center Seattle, WA USA
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HIV Positive? Take Control Find a provider you trust Build a support system Learn about your disease Learn about your treatment options No Treatment Treatment by Prescription Clinical Trials
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What is a Clinical Drug Trial? Drug trials are also called clinical trials or studies. A trial is a controlled experiment in which people take a drug to find out if it works and if it is safe. It is necessary to prove that a drug is safe and effective before it can be legally sold in most countries, including the US.
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HIV Clinical Drug Trials Who are they for? People who have never been treated for their HIV. People who have been treated before but need to change their medications. People with opportunistic infections. People who need extra guidance with taking their medications. People who want to contribute to the understanding of HIV treatment.
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Types of Drug Trials Phase I: Is the drug safe? Phase II: What dose is best and does it look like it will work? Phase III: How safe and effective is the drug in a large number of people? Phase IV: Studies after a drug is approved.
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Controlled Trials People are placed, at random, into one or more groups in the study. One group will get the investigational drug (the one being studied), and one will get the already-approved current standard treatment. Open label trials. Double blind trials.
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Open Label Trials Each person knows exactly what drugs they are getting. Randomization into groups often occurs. The investigator usually does not have control over this process. The study personnel know what drugs everyone is getting. There are no secrets here.
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Double-Blind Trials The most scientific way to run a study.
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