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Participating in a Clinical Trial
A factsheet from the New Mexico AIDS InfoNet
What is an AIDS clinical trial?
Before new drugs can be sold to treat HIV disease, they must be proved to be safe and effective. The Food and Drug Administration (FDA) approves new drugs and other treatments based on the results of laboratory tests, animal tests, and tests in humans (clinical trials).
New treatments are tested in humans only if there were good results from laboratory tests and animal studies. In the first clinical trials, the treatment is tested for safety in a small group of people. Later trials with many more participants test how well the treatment works. InfoNet Fact Sheet 105, How Drugs Get Approved, has more information on the phases of clinical trials.
A clinical trial is a carefully planned medical experiment. The guidelines for a clinical trial are called a protocol. The protocol is a document that describes exactly how the trial will be carried out.
Who can participate in a clinical trial?
The protocol explains the rules for participation in a clinical trial. Each trial is different. For example, some trials require certain viral loads or T-cell counts.
Should I participate?
You and your doctor should discuss the possible benefits and risks of taking part in a clinical trial. Here are some of the questions you should consider:
- What is the purpose of the study?
- How long will it last?
- Where is it being conducted?
- How will I take the medication (pills, shots, intravenous infusion, other?)
- What else do I have to do (records to keep, office visits, etc.)?
- What will I have to pay for?
- Can I be reimbursed for travel expenses?
- Is child care available?
- Will I be able to stay on the study treatment after the trial is over? Who will pay for it?
- What was learned in previous studies of this treatment?
- Will I have to stop any drugs or other treatments I am now using?
- Will taking part in this study exclude me from other clinical trials?
To find out more about clinical trials:
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For information about participating in clinical trials or trials availability throughout the U.S., call the AIDSinfo Health Information Service at 1-800-448-0440, or visit their Internet website at http://aidsinfo.nih.gov.
- The FDA website has information on the drug development process at http://www.fda.gov/cder/handbook/dev_rev.htm.
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