HIV Overview

HIV and AIDS Clinical Trials

Last Reviewed: August 13, 2021

Key Points

  • A clinical trial is a research study done to evaluate new medical approaches in people. 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.
  • The benefits and possible risks of participating in an HIV and AIDS clinical trial are explained to study volunteers before they decide whether to participate in a study.
  • Use the find a study 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 that evaluates new medical approaches in people. These approaches include:

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

Clinical trials are conducted in several phases to determine whether new medical approaches 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 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.

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
All the medicines used to treat HIV/AIDS in the United States were first studied in clinical trials.

Can anyone participate in an HIV and AIDS clinical trial?

It 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, HIV treatment history, or other medical conditions.

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

Participating in an HIV and AIDS clinical trial can provide benefits. For example, 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.

Participants in clinical trials 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.

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 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 looking for volunteer participants.

  • Use the find a study search feature on ClinicalTrials.gov to find HIV and AIDS studies looking for volunteer participants.
  • Call a Clinical  Info health information specialist at 1-800-448-0440 or email ContactUs@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.