About the Clinical Trials Process

A clinical trial is a carefully designed research study in which a treatment or therapeutic process in development is tested in people. A clinical trial may vary in length from a few weeks to several years. HIV/AIDS clinical trials, the type run by the AIDS Clinical Trials Group (ACTG), are designed to answer specific questions about the safety and effectiveness of different treatments for HIV/AIDS and related conditions.

An ACTG clinical trial may study experimental medications to treat HIV and AIDS, or to prevent or treat HIV-related infections. ACTG studies may also look at a possible new use for a medication that has already been tested and government-approved, or may study ways to help people manage their HIV/AIDS medications or long-term general health.

Clinical trials are the gold standard of modern medicine. They are the only direct way to learn how different people respond to medications, treatments, or therapeutic approaches. All treatments for HIV/AIDS and related conditions must be tested through clinical trials before they can be approved. HIV/AIDS clinical trials provide critical information to help people living with HIV to live longer, healthier lives.

All ACTG clinical trials are subject to extensive review. Detailed study plans, also known as the study “protocol,” are reviewed extensively by research experts and ethicists. Each clinical trial is also reviewed by an Institutional Review Board (IRB), a diverse group of experts that must approve the trial. The IRB also reviews ongoing clinical trial operations periodically to ensure that the study is being conducted properly, that any risks from participating are as low as possible, and that any risks are outweighed by the potential benefits of the study.

To ensure reliable results, clinical trials follow precise research plans called protocols. The protocol describes every aspect of a research study, including the study timeline and processes and what question or questions the study hopes to answer.

The clinical trial process generally follows four key phases. A study can be either a Phase 1, 2, 3 or 4 trial, depending on where the treatment being studied is in its development.

• Phase 1 Trials: Provide a study medication to a small group of people for the first time, to measure its safety.
• Phase 2 Trials: Provide a study medication to larger groups of people to see if it works and to further evaluate its safety.
• Phase 3 Trials: Provide a study medication to very large groups of people to develop information that will allow the drug to be marketed and used safely.
• Phase 4 Trials: Provide additional information about the study medication after it has been approved for marketing

HIV/AIDS clinical trials are developed by the AIDS Clinical Trials Group (ACTG) protocol team members and supported by pharmaceutical companies. The National Institutes of Health (National Institute of Allergy and Infectious Diseases, Division of AIDS) sponsors the ACTG clinical trials network.

Different clinical trials have different requirements, or criteria, for their participants. When selecting participants, researchers may consider a number of factors, which can include the participant’s age, sex, health status (things like your CD4 or T-cell count, HIV viral load, past medical history, or medication history), and willingness and ability to follow the trial’s instructions and schedules.

Study participants may be among the first people to receive a new experimental medication. Other benefits include receiving HIV/AIDS health care related to the research study by HIV-experienced physicians and study nurses, and helping others by adding to the medical information available about HIV/AIDS. The medications, clinic visits, evaluations, and laboratory tests required by the research study will usually be provided to participants free of charge. Medical information obtained during the clinical trial can be shared with your own health care provider.

A study medication may not be helpful to you, or might cause harm, including side effects. Anyone considering participating in a clinical trial will receive full information on possible side effects from the study staff and in the study consent form. Participants may not be able to continue with their current treatments while in the study, and may not be able to continue receiving the tested drug after the study ends.

All ACTG clinical trials are subject to strict, mandatory safeguards that are designed to reduce any risks to study participants. Each clinical trial is reviewed, approved, and monitored by an Institutional Review Board (IRB). Some trials also have community advisory boards. In addition, all study participants must read and sign informed consent documents. These documents ensure that participants understand the risks and potential benefits of participating in the study, as well as their rights and responsibilities as study volunteers.

Anyone who wishes to join a clinical trial must understand everything about the study – including the potential risks and benefits and all of the obligations of participating. If an individual qualifies for a study and is interested in participating, the research staff will explain the study in detail and answer any questions the potential volunteer has. When the study has been fully explained and all questions have been answered, the participant will be asked to read and sign a document stating that they give their informed consent to participate in the study. The participant will receive a copy of the consent form.

Anyone interested in participating in a clinical trial should feel free to ask any and all questions they have about the study, and to have all answers explained to them until they feel comfortable with the information. Questions that a potential participant might ask include:

• What is the purpose of the clinical trial?
• What will I need to do to join the clinical trial?
• Are there already-approved treatments available for my medical condition?
• How do the treatments used in this study compare with any available treatments?
• Will I know what drug I am taking in the study?
• How often will I need to come to appointments, use study medications, and have medical tests?
• What side effects might I experience if I participate?
• What should I do if I experience side effects, feel uncomfortable, or have questions during the clinical trial?
• How will my confidentiality be protected?
• What kind of long-term follow up care will be provided as part of the clinical trial?
• Will there be any costs involved in participating?

A list of ACTG clinical trials currently open for enrollment is available here. The list is updated frequently, so please feel free to check back for updates.

Each study description includes a list of Participating Sites, so you can see if a study of interest is being conducted at a site near you, along with contact information for each study site. The site contact person can provide you with any information you need about studies they are conducting. Your conversation will be completely confidential. You do not need to give your name or phone number to receive this information.

If you are interested in and potentially eligible for a study, you will be invited to make an appointment for a screening visit at the clinic. The study staff may ask you to bring your medical records, including HIV-related and other significant medical history, HIV medication history, and recent laboratory results.

During the screening visit, the study will be reviewed in detail and you will have an opportunity to ask any questions. If you decide to participate, the study nurse will review a consent form with you and ask you to sign the form to give permission to proceed with the screening evaluations. In most screening visits, blood samples will be drawn and you will be examined by the study doctor to determine whether you meet the study eligibility criteria.

If screening tests show that you qualify to enter the study, the study nurse will schedule an entry visit. Lab tests will be done to get baseline values, and you will receive your study medication. During this visit the study medication dosing will be reviewed with you and you will receive information about possible side effects and phone numbers to call with questions or problems.

The frequency of your visits to the clinic will depend on the study. Most follow-up visits consist of a brief physical exam, lab tests, and a review of your study medications.

The clinical research staff will be in close communication with your physician. Your physician will receive copies of the lab results obtained through the study. The study staff will also contact them if you have any trouble with the study medication to discuss management and any changes needed in your study medication.

Check out the following videos for participant perspectives in their own words:

• Minority Perspectives on Clinical Trials (in English)
• Minority Perspective on Clinical Trials (in Spanish)/Perspectivas de las minorías en los ensayos clínicos del VIH/SIDA
• HIV Clinical Trials: A Community Q &A (in English)