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Clinical Trials

Clinical Trial Basics

A clinical trial is a research study with human volunteers. The purpose of a clinical trial is to answer specific health questions. Many clinical trials are done to see if a new drug, device, or technique is safe and effective for people to use.

HIV/AIDS clinical trials are research studies that test new treatments, diagnostic tests, and prevention strategies for HIV/AIDS. These studies are carried out by physicians and other health professionals and researchers. Clinical trials are the safest and fastest way to find HIV treatments that work.

There are two kinds of clinical trials:

  • Interventional trials use controlled conditions (including a planned intervention or experiment) to determine whether a new treatment (or an existing treatment that is being used in a new way) is safe and effective.
  • Observational trials gather information about health issues from groups of people without any intervention.

In the first phase of clinical trials, experimental therapies are given to small numbers of people to help determine safe doses. If these therapies are found to be safe, the treatments are then administered to a larger group.

Clinical Trial Protocol

The U.S. Food and Drug Administration (FDA) establishes research plans (known as protocols) that determine who can participate in a clinical trial. The protocols also determine how long the trial will last, schedules for tests and procedures, and the types of drugs (and dosages) that people taking part in the trial will take. In order to participate in a specific clinical trial, you have to agree to the protocols—and not everyone is eligible to participate. To find out if you are eligible to participate in a clinical trial, talk to your healthcare provider and visit NIH’s Are Clinical Studies for You?

For more information about clinical trial protocols, see FDA’s Basic Questions and Answers about Clinical Trials.

Benefits of HIV/AIDS Clinical Trials

There are some good reasons to consider participating in a clinical trial. You could:

  • Gain access to new treatments not available to the public
  • Receive expert medical care at leading healthcare facilities
  • Have a chance to help others by contributing to medical research
  • Get experimental medications (They may even be free!)

Risks of HIV/AIDS Clinical Trials

But before you participate in a clinical trial, you need to consider some of the risks:

  • Experimental drugs may not have any benefits or may even be harmful.
  • New drugs may have unanticipated side effects.
  • Protocols may require a lot of your time and frequent trips to the study site.

For more information, see NIH’s What Is an AIDS Clinical Trial?

Frequently Asked Questions

What happens during a clinical trial?

The clinical trial process depends on the kind of trial. The team will include doctors and nurses, and possibly other healthcare professionals, social workers, etc. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.

For more information, see AIDSinfo’s Clinical Trials FAQs.

Last revised: 10/11/2010