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HIV Clinical Trials FAQ

October 2010

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Does it Cost Anything to Join a Clinical Trial?

There is no cost to participate in a clinical trial. Trial medication is usually free and the study sponsors cover the cost of any lab tests related to the study. However, most trials expect your private insurance or Medicaid to pay for additional lab tests not required by the study and other medications you may be using.

It is important to consider that there may be a significant amount of time required to participate in a study. You may have to take time off from work or cover additional childcare expenses. Some clinical trials will pay you a set fee to compensate for your time and any additional expenses you incur in order to participate in the study, such as childcare or transportation expenses.

What Is a Placebo?

A placebo is commonly known as a sugar pill. It is a substance that looks identical to the trial medication (whether it is a pill, liquid, or shot) but does not contain any active drug. Placebos have no effect on the body. In a clinical trial the investigators sometimes compare an experimental drug with a placebo to determine if the experimental drug works.

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If a trial you are considering uses a placebo, find out if you will eventually have a chance to get the experimental medication as part of your participation in the trial if the drug is shown to work.

Are All Clinical Trials Sponsored by the Government?

No, not all studies are sponsored by the government. However, federal agencies, such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), sponsor clinical trials in collaboration with a variety of organizations, universities, and pharmaceutical companies. Clinical trial locations vary by study, but enrollment sites are generally a university, hospital, doctor's office, or community clinic.

What Is Expanded Access?

Expanded access programs provide drugs that are not yet FDA approved, usually for free, once there is enough information to show safety and efficacy. Expanded access programs allow the drug company an opportunity to collect information about how the drug works in very large groups of people who are not in a controlled clinical trial. In addition, expanded access programs allow people with HIV access to a new treatment before it's available to the general public for purchase. There are usually a limited number of spots and certain requirements you must meet to be eligible for expanded access

If you feel you may benefit from an experimental treatment, but you do not meet the inclusion criteria for the clinical trial testing this treatment, you should talk to your doctor to find out if expanded access is available.

Are There Other Ways to Receive Free Treatment for HIV?

Participating in a clinical trial or an expanded access program are good ways to receive free experimental treatments for HIV, however once the drug is approved each drug company has a patient assistance program available for people who are uninsured and can not afford their medications. In addition, in the United States, every state has an AIDS Drug Assistance Program (ADAP) and a Medicaid program, which may provide you with FDA-approved medications if you qualify.

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This article was provided by The Well Project. Visit The Well Project's Web site to learn more about their resources and initiatives for women living with HIV. The Well Project shares its content with TheBody.com to ensure all people have access to the highest quality treatment information available. The Well Project receives no advertising revenue from TheBody.com or the advertisers on this site. No advertiser on this site has any editorial input into The Well Project's content.
 
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