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       Clinical trials

                Clinical trials are research studies. They can be used to answer questions about new ways of
                treating HIV disease and preventing HIV related infections. Questions that a clinical trial may
                answer include:

                Does a drug prevent or treat HIV related infections?

                What is the best dosage of the drug?

                Is the drug safe for people to take?

                Are there side effects?

                Does the drug cause problems when it is taken over a long period of time?
 

            The protocol

               Clinical trials are run by doctors and other health workers who use a set of rules called a
               protocol. The protocol explains exactly how the trial will be run and who may enroll. It also
               helps doctors and nurses by telling them what a drug dosage is used in the study and how often
               patients would be checked for side effects.

            Patient requirements

               To be in a clinical trial:

               You must have a disease that is being studied or be at risk for it.
               You must be able to take the drug being studied
               You must be able to follow the study rules

                Before you enter the study, the medical team will make sure that you can take part by asking
                you questions about your health, performing an exam and doing lab tests.

            Clinic visits

               After you enter a trial, you will need to go back to the doctor's office or clinic for regular visits.
               During these visits, the doctor or nurse will check you for side effects and signs of whether the
               drug is working. If no problems result from taking the study drug, the treatment will continue
               until the end of the study. Some studies can last several years.

               If you decide that you no longer want to take the study drug, you can stop taking it. Just be sure
               that your doctor knows about your decision. If the drug does not work for you, or if it causes
               harmful side effects, your doctor will stop your treatment. If you stop taking the drug for any of
               these reasons, you will still be in the study, and you will need to continue your clinic visits until
               the study ends. Of  course your are free to withdraw from the study at any time. If you get sick
               from taking the study drug, the people running the trial will make sure that you have access to
               medical care.

            Patient information

               In the past, people in clinical trials were not always treated well. Sometimes they were allowed
               to get sick even when there was a cure for their illness. Now there are laws that protect your
               rights as a patient in a clinical trial.

               One of these laws requires doctors running a trial to enroll patients only after they have given
               informed consent. This means that the doctors must tell you everything that would affect
               whether or not you would want to be in the trial. Also, before you enter the trial, the doctors
               must have your agreement in writing that you have been given this information and that you are
               willing to take part in the study.

            Protecting patients' rights

               People in clinical trials are also protected by outside groups.

                    Institutional Review Board (IRB)
                    Food and Drug Administration (FDA)
                    Community Advisory Board (CAB)
 

               The Institutional Review Board is a community group that includes people who know about
               medicine and research. The IRB reviews a trial before it begins and every few months after it
               begins. If the people in the trial are being harmed or their rights are not being respected, the IRB
               will stop the trail.

               Another group that works to protect people in clinical trials is the Food and Drug
               Administration. The FDA makes sure that the study drugs have been tested enough to be used
               in clinical trials. They also make sure that an approved treatment would never be withheld form
               people in a clinical trial.

               The Community Advisory Board is a community group that may include people with AIDS. The
               people in this group know a great deal about research and patients' rights. They review and help
               write protocols to make sure that patients' concerns are addressed.

            Questions about clinical trials

                If you are about to take part in a clinical trial, think about asking your doctor or nurse:

                What are the side effects of the study drug?
                How is the study drug taken?
                Are there any drugs, food etc.. that I should no take while I am taking the study drug?
                Has the study drug been used before?
                What other treatments choices do I have?
                How long will the study last?
                How often will I have to go to the clinic?
                Will I have to be in the hospital?
                Will I be given travel money for this study?
                How will my part in the study be kept secret?
                Who will provide my medical care after the study is over?
                Can I get the drug once the study is over?
                Who do I call if I have more questions?