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What is an AIDS Clinical Trial?

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Table of Contents

What is an AIDS clinical trial?
What is an AIDS clinical trial protocol?
Benefits of AIDS Clinical Trials
Risks of AIDS Clinical Trials
Questions to ask
How to find information about clinical trials on HIV and AIDS

What is an AIDS clinical trial?

AIDS clinical trials are research studies in which new therapies for AIDS and HIV infection are tested in humans. These studies are conducted by physicians and other health professionals and can help determine the usefulness of experimental drugs and biologicals in treating HIV disease. Carefully conducted clinical trials are the fastest and safest way to help find treatments that work.

New therapies are tested in humans only after laboratory and animal studies show promising results. In the first clinical trials, the experimental therapies are given to small numbers of people to help determine safe doses. Larger groups of patients may then receive the therapies to help measure effectiveness. The treatments may then be used in even larger studies to compare the new treatment to ones already in use or to help estimate other effects of the product.

What is an AIDS clinical trial protocol?

Clinical trials are based on a set of rules called a protocol. The protocol describes what types of patients may participate in the clinical trial, schedules of tests and procedures, drugs and dosages, and the length of the study. Each patient participating in a clinical trial must agree to be treated by the rules of the protocol. For most studies, researchers test groups of people who are alike in medical status. For this reason, not everyone interested in participating in a clinical trial is eligible.

Benefits of AIDS Clinical Trials

  • Patients gain access to new treatments not available to the public.
  • Patients receive expert medical care at leading health care facilities.
  • Participants have a chance to help others by contributing to medical research.
  • Experimental drugs are often provided free of charge.
Risks of AIDS Clinical Trials

  • 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 the patient’s time and frequent trips to the study site.
Questions to ask

If you are interested in participating in a clinical trial, you may want to ask:
  • How often will I have to go to the clinic?
  • What are the drug’s side effects?
  • What other treatment options do I have?
  • What other drugs can I take if I participate in the study?
  • What treatments must I avoid while participating in the study?
  • What is the purpose of the study?
  • Will I have to be in the hospital?
  • Who will pay the costs of the study?
  • How long will the study last?
  • How will my confidentiality be protected?
  • Who will provide my medical care after the study is completed?
  • Am I committed enough to stay with the clinical trial until it is complete?
How to find information about clinical trials on HIV and AIDS

AIDSinfo has been established to provide free, up-to-date information on clinical trials that evaluate experimental drug and biological treatments for adults and children with HIV infection and AIDS.

To find out more about AIDS clinical trials, call AIDSinfo toll free. Callers can speak with experienced health specialists who can answer questions concerning the clinical trial’s purpose, location, eligibility requirements, names and telephone numbers of the contact persons, and more. Bilingual specialists are available to talk with Spanish-speaking callers.

To contact AIDSinfo toll free from the United States or Canada call:

1-800-HIV-0440 (1-800-448-0440)
Fax: 1-301-519-6616
International: 1-301-519-0459
TTY: 1-888-480-3739
Web site:
In addition, the National Library of Medicine offers online computer access to information on AIDS clinical trials (free of charge) through its MEDLINE subscriber service and through the NLM and AIDSinfo World Wide Web sites. For more information about NLM, call: 1-800-638-8480 or 1-301-496-3147.
Web site:

AIDSinfo is a U.S. Department of Health and Human Services (DHHS) project sponsored by the following U.S. Federal government agencies: National Institute of Health: Office of AIDS Research, National Institute of Allergy and Infectious Diseases, National Library of Medicine; Centers for Medicare and Medicaid Services, Health Resources and Service Administration; and Centers for Disease Control and Prevention.