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            Placebos

         A placebo is a tablet or capsule that contains no drug, but looks and tastes like a tablet or
                capsule that does contain a drug. Placebos can play an important role in clinical trials by
                helping doctors test new treatments for patients with HIV infection and AIDS.

                Placebos may cause a positive response in some patients. This response may be related to:

                    Medical attention and support- the act of taking a pill or capsule gives some patients an
                    increased feeling of medical support.

                    Patients' attitudes- if you believe a pill of capsule you are taking will work, you may
                    experience benefits.

                    Doctors' attitudes- your doctor's opinion about a pill or capsule you are taking may affect
                    your response to that pill or capsule.

                In placebo controlled trials, patients may be separated into two or more groups.   The treatment
                groups will be assigned to take a drug while the other group will be assigned to take a placebo.
                Placebo-controlled clinical trials compare the response of patients in the placebo group to that
                of patients receiving drug. by doing this, doctors can be certain that benefits experienced by the
                treatment group are caused by the drug and not by the act of taking tablets or capsules.

                Placebos may also be used in blinded clinical trials that compare different drugs. In these trials,
                patients in each group take one of the study drugs and the placebos for the other drugs. The
                placebo is given so that neither the doctors nor the patients know who is getting which drug.
                This is important in trials in which the patients and/or doctors may have a preference for one
                study drug over another study drug.

                Patients taking placebos in clinical trials may do better than patients who take the study drug
                itself. When this happens, we know that either the drug is not working well or it is causing
                harmful side effects. For this reason, placebos are used in research so that fewer patients are
                exposed to the risks of taking a new drug.

             Common patient concerns about placebo-controlled trials may include:

                    Taking additional pills- when you take part in a placebo-controlled trial, you may need to
                    take additional tablets or capsules. This is done so that neither you nor your doctor will know
                    if you are taking the study drug or the placebo.

                    Feelings of anxiety- some patients worry about whether they are receiving placebo or drug.

                    Feelings of unfairness- patients may feel it is unfair or unethical to use placebos. However,
                    when there is a proven effective treatment for patients in a trial, placebos are not used. All
                    patients who enter placebo-controlled trials have the same chance of being assigned to the
                    placebo of the treatment group.
 

                Deciding to participate in a placebo controlled trial requires that you:

                Understand how the clinical trial works and what your treatment options outside the clinical
                trial include

                Discuss the pros and cons of taking the drug with your doctor

                Discuss your chance of being assigned to the placebo versus the treatment group with your
                doctor

                Comply with the requirements of the trial and take only those medications prescribed by your
                doctor

                If you want to talk more about placebos, please contact your doctor or nurse.