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What is a clinical trial?
A clinical trial is a study that allows doctors to determine the usefulness and safety of new treatments or to compare a promising new treatment to another standard treatment. Clinical trials are the only way to find out if a drug works and if it is safe for people to take. Any drug that might improve the lives of people with HIV disease must go through careful testing before it will be made widely available to the hundreds of thousands of people who need treatment.
Just a few years ago, almost no drugs existed to treat people with HIV. Today drugs are available that help people with HIV live longer, stay well longer, and treat or prevent problems caused by AIDS. These drugs were proven to work because people with HIV helped test them. Most studies today compare an investigational drug or set of drugs with the one now being used to see which treatment works better. The ACTU is looking for men and women to help test drugs for HIV and it’s complications.
Can anyone with HIV join a clinical trial?
To participate in an AIDS clinical trial, an individual must qualify for a study. Qualifications are different for each study and may include a person’s age, symptoms and past treatments. The ACTU will evaluate all interested HIV-positive volunteers for possible inclusion in clinical trials.
Why do people take part in clinical trials?
People choose to participate in clinical trials for many reasons. Clinical trials can be a treatment option or enhance treatment. Participants in a trial are followed closely by the same medical team. When a medicine is proven to work, all those participating in a trial are the first to benefit. All or most of the treatment drugs and tests given in the trial are free. A clinical trial may benefit the participant by offering a new treatment for the disease, improved health or a way to feel better. Joining a study means taking positive action. Many people are eager to participate in clinical trials because they want to contribute to an effort that may help others. The sooner studies are completed, the sooner improved methods of treatment will be available.
What types of treatments are being studied?
Are the study drugs safe?
Before a drug is given to people, it is first studied in the test tube and in animals to look for dangerous side effects. Before a clinical trial can begin, the drug must be approved by the Food and Drug Administration, a panel of doctors, experts and other concerned individuals. Each unit that conducts a trial is by law responsible for protecting the rights and confidentiality of people in the trial and for ensuring that the trial is ethical and as safe as possible. Individuals in a treatment trial are watched carefully, because the investigational drug may have side effects. This allows the unit staff to take steps to try to prevent or treat side effects if they do occur.
What is informed consent?
The principle of informed consent requires that people who are being asked to join a clinical trial understand a number of important things about the trial; the purpose, the drug that will be used, the possible dangers and benefits of the drug, the number of clinic visits needed, and the test that will be done. Consent is obtained before a person enrolls in a trial. A person may choose to leave the study at any time.
The ACTU’s Response to AIDS
Acquired Immune Deficiency Syndrome (AIDS) is one of the most critical health issues facing our nation today. The number of people affected by HIV (human immunodeficiency virus, the virus that causes AIDS) continues to grow. People with HIV and the medical communities are seeking answers to the many questions about HIV/AIDS. Clinical trials have helped to find better treatments and increase our knowledge of this disease, but extensive study must continue until a cure is found. Since 1992, The University of Texas Medical Branch at Galveston has been one of several national research institutions designated an AIDS Clinical Trials Unit (ACTU). Supported by the National Institutes of Health, the units are committed to improving the understanding of the AIDS virus and the development of effective treatment.
The ACTU at Galveston is seeking individuals who are infected with HIV for evaluation to participate in clinical trials concerning HIV/AIDS.
What are the responsibilities of people who enroll in a trial?
In order to be useful, trials must be run according to a set of rules that must be understood and followed. The first responsibility of study participants is to understand what the rules are and to be honest about their ability to follow them. Typical rules include taking medicine every day at the same time and letting the unit staff know what other medications are being taken. Some trials may require many lab tests and visits to the clinic. These rules should be considered in the decision to participate.
Even though tests and restrictions might seem like a burden, they are designed to protect patients from unknown side effects and to obtain reliable information about the drug being tested. For this reason, it is very important to keep clinic appointments. Making the effort to follow the rules can help everyone.
Are there any fees?
Experimental drugs and related tests are provided by the ACTU free of charge. However, the unit is unable to cover all costs of services that are outside the scope of a particular study. These costs may be covered by private medical insurance or other funding sources.
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Currently Enrolling ACTU Studies
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