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New hope for HIV-Related depression: which drug works better?

NCT ID NCT06705478

Symptom relief Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study compares two drugs, pramipexole and escitalopram, to treat major depression in people with HIV. Some participants also have mild memory or thinking problems. The goal is to see which medication is safer and more effective at easing depression symptoms. About 186 adults will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 186 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented HIV-1 infection. * Diagnosis of MDD. * On current ART regimen for at least 90 days prior to study entry with no interruption in treatment greater than 7 consecutive days. * No plans to change ART while on study. * Plasma HIV-1 RNA levels of less than 200 copies/mL obtained within 90 days prior to enrollment. * Study candidates previously treated for depression are eligible provided the study candidate's last dose of antidepressant taken is at least 4 weeks prior to study entry, with the exception of fluoxetine, which the last dose taken must have been at least 8 weeks prior to study entry. * Laboratory values obtained within 30 days prior to study entry that meet protocol criteria as determined by the site investigator of record. * Study candidates of child-bearing potential must have a negative serum or urine pregnancy test performed at screening and within 2 days prior to study entry. * Study candidates of child-bearing potential who are participating in sexual activity that could lead to pregnancy must agree to use at least one highly effective method for contraception. Exclusion Criteria: * Active suicidality, and/or severe MDD, psychotic disorders, manic or hypomanic symptoms occurring in the context of bipolar disorder type I or II, or cyclothymic disorder, or another current Axis I diagnosis judged by the investigator to interfere with the trial. * Study candidate self-report of depressive symptoms that have persisted for over 50 percent of waking hours and for over 50 percent of days over the 24 months prior to study entry. * Severe, active alcohol or substance use disorder by DSM-5-TR criteria in the 6 months prior to study entry. * Active alcohol or substance use judged by the investigator to interfere with the trial. * Any acute infection within 14 days prior to study entry. * Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry. * Active coronary artery disease (CAD) or myocardial infarction (MI) within 180 days prior to study entry. * Presence of rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus (SLE), dermatomyositis, ulcerative colitis, Crohn's disease, or other chronic inflammatory conditions. * Immune reconstitution inflammatory syndrome (IRIS) or a history of IRIS within 180 days prior to study entry. * Unstable or advanced liver disease. * Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function within 30 days prior to study entry. * Non-HIV-associated neurological disorder comorbidity. * Diagnosis of epilepsy with antiepileptic drug treatment. * Untreated HCV infection and HCV viremia. * Current CNS malignant tumor or CNS opportunistic infection (OI). * Current systemic malignant tumor or of a current systemic AIDS-defining OI. * History of completed treatment of CNS or systemic malignant tumor within the 5 years prior to study entry. * History of completed treatment of CNS OI within the 5 years prior to study entry. * Documented history of completed treatment of systemic AIDS-defining OI, as well as Mycobacterium Tuberculosis Infection, within the 180 days prior to study entry. * New diagnosis of syphilis or treatment for syphilis within the 180 days prior to study entry. * History of neurosyphilis. * Severe chronic obstructive pulmonary disease. * Congestive heart failure (CHF). * Use of systemic steroids daily (except testosterone). * Diseases that cause a known bleeding diathesis. * Immunostimulant therapies and trials of non-FDA-approved ARV medications within 30 days prior to study entry. * Immunosuppressive medications if judged by the investigator to affect study outcomes. * Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding. * Known allergy/sensitivity or any hypersensitivity to the study drugs or their formulations. * Study candidates on prohibited medications at the time of screening will be excluded from study participation. Inclusion Criteria for Participants at US Sites Who Consent to the Lumbar Puncture (LP) Procedure: * Non-focal neurological examination. Study candidates with focal findings should have expert assessment for mass effect prior to the LP. * Laboratory values that meet LP protocol criteria as determined by the site investigator. Exclusion Criteria for Participants at US Sites who Consent to the LP Procedure: * Current use of anti-coagulants. * Known presence of intracerebral mass or lesion that is judged to affect the safety of an LP. * Known presence of an active CNS infection that could alter CNS/CSF inflammatory measures. * Known allergy to lidocaine. * Individuals who are unable to safely tolerate an LP due to physical limitation or condition. * Body mass index (BMI) greater than 40 kg/m\^2.

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Conditions

The condition(s) this trial relates to.

cognitive disorder HIV infectious disease major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Major depressive disorder Mild neurocognitive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alabama CRS

    Birmingham, Alabama, 35222, United States

  • Barranco CRS

    Lima, 15063, Peru

  • Blantyre CRS

    Blantyre, 265, Malawi

  • Byramjee Jeejeebhoy Medical College (BJMC) CRS

    Pune, Maharashtra, 411001, India

  • Case CRS

    Cleveland, Ohio, 44106, United States

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599-7215, United States

  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

    Chiang Mai, 50200, Thailand

  • Cincinnati CRS

    Cincinnati, Ohio, 45267-0405, United States

  • Columbia Physicians & Surgeons (P&S) CRS

    New York, New York, 10032, United States

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

    Dasmariñas, Cavite, 4114, Philippines

  • Durban International CRS

    Mount Edgecombe, 4302, South Africa

  • Gaborone CRS

    Gaborone, Botswana

  • Greensboro CRS

    Greensboro, North Carolina, 27401-1020, United States

  • Hanoi Medical University (HMU)

    Hanoi, 10000, Vietnam

  • Harbor University of California, Los Angeles Center CRS

    Torrance, California, 90502, United States

  • Houston Advancing Research Team CRS

    Houston, Texas, 77030, United States

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro, 21040-900, Brazil

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

    Porto Alegre, Rio Grande do Sul, 91350-180, Brazil

  • Joint Clinical Research Centre (JCRC)/Kampala CRS

    Kampala, Uganda

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

    Kericho, Rift Valley, 20200, Kenya

  • Massachusetts General Hospital CRS (MGH CRS)

    Boston, Massachusetts, 02114, United States

  • Milton Park CRS

    Milton Park, Harare, Zimbabwe

  • Moi University Clinical Research Center (MUCRC) CRS

    Eldoret, Rift Valley, 30100, Kenya

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

    Newark, New Jersey, 07103, United States

  • Northwestern University CRS

    Chicago, Illinois, 60611, United States

  • Nutrición-Mexico CRS

    Mexico City, Tlalpan, 14080, Mexico

  • Ohio State University CRS

    Columbus, Ohio, 43210, United States

  • Penn Therapeutics CRS

    Philadelphia, Pennsylvania, 19104, United States

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

    Pathum Wan, Bangkok, 10330, Thailand

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308-2012, United States

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103, United States

  • University of California, Los Angeles CARE Center CRS

    Los Angeles, California, 90035, United States

  • University of California, San Francisco HIV/AIDS CRS

    San Francisco, California, 94110, United States

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045, United States

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Adult HIV Therapeutic Strategies Network CRS

    Rochester, New York, 14642, United States

  • Vanderbilt Therapeutics (VT) CRS

    Nashville, Tennessee, 37204, United States

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110-1010, United States

  • Weill Cornell Chelsea CRS

    New York, New York, 10010, United States

  • Weill Cornell Uptown CRS

    New York, New York, 10065, United States

  • Whitman-Walker Institute, Inc. CRS

    Washington D.C., District of Columbia, 20009, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.