STUDY BASICS
Are you HIV-positive and have you been prescribed antiretroviral therapy (ART) for at least 6 months? Do you have trouble taking your daily ART medications or keeping clinic appointments? If so, you may be eligible to participate in a research study to help find out if monthly injections of two different long-acting antiretroviral drugs are safe and effective. Compensation provided.
STUDY PURPOSE
HIV (human immunodeficiency virus) is a virus that attacks the immune system. Without a strong immune system, the body has trouble fighting off infections and diseases. Antiretroviral therapies that reduce the amount of virus in the body can help people with HIV stay healthy, but taking daily medications by mouth can be a challenge for some people. The purpose of this study is to help researchers find out if monthly injections of long-acting antiretroviral drugs are safe and effective for people who are HIV-positive and have trouble taking daily medications. Researchers hope their findings will lead to better ways to deliver antiretroviral medications and improved health for people who are HIV-positive in the future.COULD THIS STUDY BE RIGHT FOR YOU?
- Ages 18 and up
- HIV-positive
- Have been prescribed antiretroviral therapy (ART) for at least the past 6 months
- Have trouble taking your daily ART medications or a history of missing clinic visits
- Not pregnant or planning to become pregnant; not breastfeeding
- Do not have uncontrolled seizures, advanced liver disease, chronic hepatitis C or active hepatitis B infection
WHAT PARTICIPANTS CAN EXPECT
Participation lasts between 24 and 180 weeks and includes up to 46 visits. Most visits last about 1-2 hours. There are four steps in the study:- During Step 1, you will begin to take a standard of care oral regimen of antiretroviral therapy (ART). There are 10 visits during this step.
- If you are successful in Step 1, you will be moved to Step 2. For Step 2, you will be randomly assigned (like the flip of a coin) to either continue on the standard of care oral therapy for 52 weeks, or switch to another oral therapy for 4 weeks, followed by the injectable long-acting medications every 4 weeks for 48 weeks. There are 17 visits in this step.
- For Step 3, if you were on the oral therapy, you may opt to cross over to the injectable long-acting medications every 4 weeks for 48 weeks. If you were already receiving the injectable medications, you will continue for 52 weeks. There are 16 visits in this step.
- For Step 4, if you prefer to switch to oral antiretroviral therapy, you will enter Step 4 and be followed for 52 weeks. If the injectable medications become commercially available, and you opt to receive them, you will no longer be seen by the study. There are 4 visits in this step. Study procedures include providing medical and medication history, undergoing physical exams, providing blood and urine samples, having an electrocardiogram, and completing questionnaires.
IRB: STUDY19100239
- ACTG A5359: The LATITUDE Study: Long-Acting Therapy to Improve Treatment Success in Daily Life - A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-infected Individuals Version 1.0MEET THE RESEARCHER
Sharon Riddler
Sharon A. Riddler, MD, is Director of Clinical Research in the Division of Infectious Diseases at the University of Pittsburgh. A graduate of the Medical College of Wisconsin and the University of Pittsburgh, Dr. Riddler’s research interests include all aspects of the clinical research process, including protocol development, implementation, and analysis of results.