ACTG Launches Landmark Study Evaluating Treatments for Depressive Disorders with or without Mild Neurocognitive Disorder among People Living with HIV

CHAPEL HILL, N.C., April 24, 2026 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of study A5402, an important new study that researchers hope will expand understanding of how to best treat depressive disorders and mild neurocognitive disorder (MND) among people living with HIV. A5402 is a phase 2, randomized, open-label clinical trial evaluating the safety and efficacy of pramipexole (a drug that stimulates receptors for the neurotransmitter dopamine in the brain) compared to escitalopram (a traditional antidepressant that modulates serotonin, a different neurotransmitter) to treat depressive disorders with or without MND among people living with HIV.

Depressive disorders and MND both affect a significant portion of people living with HIV in the United States and worldwide, even when their HIV is successfully managed and treated with antiretroviral therapy (ART). People with MND have worse cognitive performance around memory, language, and multitasking than people who do not have MND. Combined, depressive disorders and MND can affect up to 80 percent of people living with HIV, a two- to four-fold increase compared to people who do not have HIV.

“ACTG is eager to gain insights from this study, because we hope that pramipexole will prove to be more effective in treating MND and depressive disorders among people living with HIV than standard antidepressant therapy,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “Given the overwhelming prevalence of these conditions among people living with HIV, it is urgent that we identify better approaches so that we can support and help improve their quality of life.”

A5402 is a multi-center trial that will enroll 186 participants between the ages of 18 and 70 who have been diagnosed with a depressive disorder with or without MND. Participants must be on ART for at least three months and be virally suppressed. Those who qualify and consent will be randomized to either receive pramipexole extended release or escitalopram for 24 weeks. A5402 is open to all ACTG clinical research sites that have mental health expertise available for consultation and referral, either at the site or locally within the institution or community.

“It is critical that we expand tools to address depression and MND, because when they remain untreated, they negatively impact health outcomes by undermining ART adherence, engagement in care, and quality of life,” said Study Co-Chair William R. Short, M.D., M.P.H., University of Pennsylvania. “Thoughtfully designed studies like this one that evaluate and advance effective and accessible treatments for depression are essential to comprehensive HIV care.”

A5402 is led by Dr. Short and Scott Letendre, M.D., University of California San Diego (Co-Chairs) and David J. Moore, Ph.D., University of California San Diego, and Shibani Mukerji, M.D., Ph.D., Massachusetts General Hospital (Vice Chairs). ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice Chair). It is sponsored by the National Institutes of Health’s (NIH) National Institute of Mental Health and National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. CIPLA provided industry support for A5402.

For more information about A5402, please visit clinicaltrials.gov.

About ACTG
ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.

Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH.

Media Contact:
Jenna Conley, ACTG
jenna@conleycommunications.net

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