Clinical Trials 101
Deciding to participate in a clinical trial is an important personal decision. AIDS Research Alliance provides this information in order to answer a few of the frequently asked questions about clinical trials.
What is an HIV/AIDS clinical trial?
An HIV/AIDS clinical trial is a study of new drugs or treatments specifically for HIV infection and AIDS. Some HIV/AIDS clinical trials study medications for specific symptoms or opportunistic infections; other studies focus on decreasing viral load and/or raising T-cell counts. Still others may look at prevention strategies like vaccines or technologies such as more sophisticated HIV tests.
What are the different phases of a study?
Drug studies have several phases before they are approved by the Federal Drug Administration (FDA) and made available to the public.
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Preclinical research is the first step of a study. The drug is first tested in test tube experiments to see if it is effective. Next, the drug is tested in animals, both for safety and efficacy.
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Phase I studies are the first time a drug is tested in humans. These tests determine if the drug is safe in humans, and if so, what dosage (e.g. milligrams) is safe. These studies are conducted in a small number of patients (usually 10-30) for a short period of time (usually 2-12 weeks). Phase I trials pose the most risk for patients because this is the first time that the drug has been tested in humans.
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Phase II studies look at the on-going safety and effectiveness of the drug and involve a moderate number of patients (50-100).
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Phase III studies are a larger evaluation of the drug’s safety and effectiveness. This usually involves a large number of patients (300-5000). Phase III studies are the final step before the FDA approves the drug. The FDA must approve all drugs before they go on the market and can be prescribed by doctors.
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Phase IV studies take place once the drug has already been approved by the FDA and is allowed to be marketed by the drug company and prescribed by physicians. Usually studies at this level involve looking at long-term side effects of the drug and its use in combination with other drugs.
Why should I participate in a clinical trial?
People participate in clinical trials for a variety of reasons, which may include:
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You may have a disease for which there is no cure or effective treatment.
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Your disease might not respond to current medication options.
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You might join a clinical trial hoping to get improved medical care.
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Clinical trials are a way to get medical care even if you are uninsured.
What should i expect when I participate?
You should expect the following:
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The clinical staff will answer all of your questions and address all of your concerns about the study.
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The study site will protect your confidentiality.
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You may have many appointments at the clinic – and it is important for you to keep all of them!
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You must take the study medication exactly as directed.
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You will need to be honest with the clinical staff and answer all of their questions as to how you feel and whether you’ve been taking the study medication correctly.
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You will be informed of any changes to the study protocol.
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You are able to leave the study for any reason at any time. You cannot, and should not, be forced into participating or continuing in a clinical trial.
What are the benefits of participating in a clinical trial?
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You may receive potentially effective new drugs that are not available to the general public. These drugs are free to you while you are on the study. You will also receive limited free medical care while on the study.
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You may receive specialized tests that you and your doctor have no other way of obtaining.
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You will be helping to insure that the study drug is safe and effective in people like you – since some drugs act differently depending on the gender and ethnicity of the user, it is important to study a diverse range of people.
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You will be contributing to the advancement of medicine by helping in the development of new medical therapies.
What are the risks involved in participating in a clinical trial?
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The drug being tested may not work.
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The drug being tested may have unknown side effects or be unsafe.
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The study may require frequent visits and blood draws.
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Some drugs require injections that may be uncomfortable.
Where do I find HIV/AIDS clinical trials?
For more information about HIV/AIDS clinical trials in Southern California, call AIDS Research Alliance at (310) 358-2429, or click for our currently enrolling clinical trials. [LINK TO ENROLLING TRIALS]
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