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HIV Clinical Trials FAQ

October 2010

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What Is a Clinical Trial?

A clinical trial is a type of research study commonly designed to determine if a new drug or vaccine is safe and effective in humans. (Scientists first study the drug or vaccine in laboratory animals to be sure that it is safe enough to begin testing in humans.)

Can Anyone Join a Clinical Trial?

Anyone can volunteer for a clinical trial, but not everyone will be accepted. Every clinical trial has entry criteria, a set of rules that select exactly who can join.

What Are Inclusion and Exclusion Criteria?

Inclusion and exclusion criteria are the rules used to determine who can and cannot participate in a specific clinical trial:

Inclusion criteria are requirements that a person must meet to participate (such as CD4 cell count, viral load, age, or other laboratory values).

Exclusion criteria are factors that prevent a person from participating either for his or her safety or to make it easier to understand the study results. For example, people might be excluded for having liver problems, or if they've already used a drug that is being studied. Women who are pregnant or breast-feeding are usually not allowed into a study because the medication may not be safe for the baby. Often there are separate studies for pregnant women.

People are never excluded from studies because of race or income or the language they speak. In fact, HIV research programs try to enroll women and members of minority groups.

What Is Informed Consent?

An informed consent document must be given to every person considering joining a trial. The document includes complete information about the trial, written in easy-to-understand language. It also contains the names of people to contact if you have questions about your rights as a research participant or want to report a problem with the trial.

Make sure the following questions are answered in the consent form:

  • What is the purpose of the study?
  • What treatment is being studied?
  • What is the schedule of required procedures?
  • How long will the study last?
  • What are the benefits and risks of participating?
  • Will I be paid for volunteering?
  • Who pays for my medical expenses while I am a participant in the study?
  • Will my personal information remain confidential even after the study has ended?

A member of the research staff will explain the details of the trial to you and give you the informed consent to read. If you agree to participate in the trial, you will be asked to sign the informed consent. If any study procedures change while you are a participant, you will be asked to sign a new informed consent. Remember, you have the right to choose to drop out of the study at any time. This decision will not affect your medical care at the clinic or doctor's office.

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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 to ensure all people have access to the highest quality treatment information available. The Well Project receives no advertising revenue from 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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