RecruitingPhase 2NCT06705478

Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

An Open-Label, Randomized Controlled Trial of Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

186 participants

Start Date

May 17, 2026

Study Type

INTERVENTIONAL

Conditions

Mild Neurocognitive Disorder Major Depressive Disorder HIV

Summary

A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial compares two medications — pramipexole extended release (a dopamine-targeting drug) and escitalopram (a common antidepressant) — for treating major depressive disorder (MDD) in people living with HIV, including those who also have mild cognitive difficulties. Depression is very common in people with HIV and can worsen thinking and memory problems, so finding effective treatments is important. Adults with documented HIV infection who are on stable antiretroviral therapy, have HIV levels below 200 copies/mL, and have a current MDD diagnosis may be eligible. Participation involves taking one of the two oral medications daily for about 48 weeks, attending regular monitoring visits, and completing cognitive and mood assessments; an optional sub-study involves a spinal fluid sample. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPramipexole ER

Tablets self-administered orally

DRUGEscitalopram

Tablets self-administered orally

Locations(41)

Alabama CRS

Birmingham, Alabama, United States

University of California, Los Angeles CARE Center CRS

Los Angeles, California, United States

UCSD Antiviral Research Center CRS

San Diego, California, United States

University of California, San Francisco HIV/AIDS CRS

San Francisco, California, United States

Harbor University of California, Los Angeles Center CRS

Torrance, California, United States

University of Colorado Hospital CRS

Aurora, Colorado, United States

Whitman-Walker Institute, Inc. CRS

Washington D.C., District of Columbia, United States

The Ponce de Leon Center CRS

Atlanta, Georgia, United States

Northwestern University CRS

Chicago, Illinois, United States

Massachusetts General Hospital CRS (MGH CRS)

Boston, Massachusetts, United States

Washington University Therapeutics (WT) CRS

St Louis, Missouri, United States

New Jersey Medical School Clinical Research Center CRS (Site ID 31786)

Newark, New Jersey, United States

Weill Cornell Chelsea CRS

New York, New York, United States

Columbia Physicians & Surgeons (P&S) CRS

New York, New York, United States

Weill Cornell Uptown CRS

New York, New York, United States

University of Rochester Adult HIV Therapeutic Strategies Network CRS

Rochester, New York, United States

Chapel Hill CRS

Chapel Hill, North Carolina, United States

Greensboro CRS

Greensboro, North Carolina, United States

Cincinnati CRS

Cincinnati, Ohio, United States

Case CRS

Cleveland, Ohio, United States

Ohio State University CRS

Columbus, Ohio, United States

Penn Therapeutics CRS

Philadelphia, Pennsylvania, United States

University of Pittsburgh CRS

Pittsburgh, Pennsylvania, United States

Vanderbilt Therapeutics (VT) CRS

Nashville, Tennessee, United States

Houston Advancing Research Team CRS

Houston, Texas, United States

Gaborone CRS

Gaborone, Botswana

Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro, Brazil

Byramjee Jeejeebhoy Medical College (BJMC) CRS

Pune, Maharashtra, India

Moi University Clinical Research Center (MUCRC) CRS

Eldoret, Rift Valley, Kenya

Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS

Kericho, Rift Valley, Kenya

Blantyre CRS

Blantyre, Malawi

Nutrición-Mexico CRS

Mexico City, Tlalpan, Mexico

Barranco CRS

Lima, Peru

De La Salle Medical and Health Sciences Institute - Angelo King Medical Research Center (DLSMHSI-AKMRC)

Dasmariñas, Cavite, Philippines

Durban International CRS

Mount Edgecombe, South Africa

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS

Pathum Wan, Bangkok, Thailand

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai, Thailand

Joint Clinical Research Centre (JCRC)/Kampala CRS

Kampala, Uganda

Hanoi Medical University (HMU)

Hanoi, Vietnam

Milton Park CRS

Milton Park, Harare, Zimbabwe

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