HIV Overview

HIV and AIDS Clinical Trials

Last Reviewed: May 14, 2024

Key Points

  • A clinical trial is a research study in which people volunteer to help find answers to specific health questions. HIV and AIDS clinical trials help researchers find better ways to prevent, detect, or treat HIV and AIDS.
  • Examples of HIV and AIDS clinical trials underway include studies of new HIV medicines, studies of vaccines to prevent or treat HIV, and studies of medicines to treat infections related to HIV and AIDS such as opportunistic infections.
  • The details on the benefits and possible risks of participating in an HIV and AIDS clinical trial are explained to volunteers before they decide whether to participate in a study, through a process called an informed consent.
  • Use the search feature on ClinicalTrials.gov to find HIV and AIDS studies looking for volunteer participants. Some HIV and AIDS clinical trials enroll only people who have HIV. Other studies enroll people who do not have HIV.

What is a clinical trial?

A clinical trial is a research study in which people volunteer to help find answers to specific health questions. These studies are conducted according to a plan, called a protocol, which include—

  • New medicines or new combinations of medicines.
  • New medical devices or surgical procedures.
  • New, different ways to use an approved, existing medicine or device.
  • New ways to change behaviors to improve health.

Clinical trials are conducted in several phases to determine whether new medical studies are safe and effective in people. Results from a Phase 1 Trial, Phase 2 Trial, and Phase 3 Trial are used to determine whether a new drug should be approved by the U.S. Food and Drug Administration for sale in the United States. Once a new drug is approved, researchers continue to track its safety in a Phase 4 Trial. 

Interventional trial and observational trial are two main types of clinical trials:

  • An interventional study tests (or tries out) an intervention—a potential drug or treatment, medical device, or procedure—in people. Interventional studies are often prospective and are specifically tailored to evaluate the direct effects of new drugs or treatments on disease.
  • An observational study does not test potential treatments. Instead, researchers observe participants on their current treatment plan and track health outcomes. Observational studies (also called epidemiologic studies) are mostly retrospective.

What is an HIV and AIDS clinical trial?

HIV and AIDS clinical trials help researchers find better ways to prevent, detect, or treat HIV and AIDS. Every HIV medicine was first studied through clinical trials. 

Examples of HIV and AIDS clinical trials include—

  • studies of new medicines to prevent or treat HIV and AIDS.
  • studies of vaccines to prevent or treat HIV.
  • studies of medicines to treat infections related to HIV and AIDS, such as opportunistic infections.

Can anyone participate in an HIV and AIDS clinical trial?

Participation in a clinical trial depends on the study. Some HIV and AIDS clinical trials enroll only people who have HIV. Other studies include people who do not have HIV.

Participation in an HIV and AIDS clinical trial may also depend on other factors, such as age, gender, pregnancy, HIV treatment history, or other medical conditions.

What are the benefits of participating in an HIV and AIDS clinical trial?

Many people participate in HIV and AIDS clinical trials because they want to contribute to HIV and AIDS research. They may have HIV or know someone who has HIV.

People with HIV who participate in an HIV and AIDS clinical trial may benefit from new HIV medicines before they are widely available. HIV medicines being studied in clinical trials are called investigational drugs. To learn more, read the HIVinfo What is an Investigational HIV Drug? fact sheet.

Another benefit of participating in an HIV and AIDS clinical trial is that participants can receive regular and careful medical care from a research team that includes doctors and other health professionals. Often the medicines and medical care are free of charge.

Sometimes people get paid for participating in a clinical trial. For example, they may receive money or a gift card. They may be reimbursed for the cost of meals or transportation. 

Are HIV and AIDS clinical trials safe?

Researchers try to make HIV and AIDS clinical trials as safe as possible. However, volunteering to participate in a study testing an experimental treatment for HIV can involve risks of varying degrees. Most volunteers do not experience serious side effects; however, potential side effects that may be serious or even life-threatening can occur from the treatment being studied. 

Before enrolling in a clinical trial, potential volunteers learn about the study in a process called informed consent. The process includes an explanation of the possible risks and benefits of participating in the study.

The FDA believes that obtaining a research participant's written informed consent is only part of the process. Once enrolled in a study, people continue to receive information about the study through the informed consent process.

If a person decides to participate in an HIV and AIDS clinical trial, will their personal information be shared?

The privacy of study volunteers is very important to everyone involved in an HIV and AIDS clinical trial. The informed consent process includes an explanation of how a study volunteer’s personal information is protected.

How can one find an HIV and AIDS clinical trial looking for volunteer participants?

There are several ways to find an HIV and AIDS clinical trial searching for volunteer participants. 

  • Use the find a case study search feature ClinicalTrials.gov to find HIV and AIDS studies looking for volunteer participants. 

  • Call a Clinicalinfo health information specialist at 1-800-448-0440 or email HIVinfo@NIH.gov 
  • Join ResearchMatch, which is a free, secure online tool that makes it easier for the public to become involved in clinical trials.