Actively Recruiting
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-03-31
186
Participants Needed
40
Research Sites
30 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
C
Cipla Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented HIV-1 infection
- Diagnosis of major depressive disorder
- On current ART regimen for at least 90 days prior to study entry with no interruption longer than 7 consecutive days
- No plans to change ART while on study
- Plasma HIV-1 RNA levels less than 200 copies/mL obtained within 90 days prior to enrollment
- Previous depression treatment allowed if last antidepressant dose was at least 4 weeks prior to entry (8 weeks for fluoxetine)
- Laboratory values within 30 days prior to entry meeting protocol criteria
- Negative pregnancy test for those of child-bearing potential at screening and within 2 days prior to entry
- Use of at least one highly effective contraception method if of child-bearing potential and sexually active
You will not qualify if you...
- Active suicidality or severe major depressive disorder
- Psychotic disorders, bipolar disorder type I or II, cyclothymic disorder, or other Axis I diagnoses interfering with the trial
- Depressive symptoms persisting over 50% of waking hours and days for 24 months prior to entry
- Severe or active alcohol or substance use disorder within 6 months prior to entry
- Any acute infection within 14 days prior to entry
- Acute or serious illness requiring systemic treatment or hospitalization within 90 days prior to entry
- Active coronary artery disease or myocardial infarction within 180 days prior to entry
- Presence of certain chronic inflammatory conditions (e.g., rheumatoid arthritis, lupus)
- Immune reconstitution inflammatory syndrome or history within 180 days prior to entry
- Unstable or advanced liver disease
- Use of medications affecting depression or neurocognitive function within 30 days prior to entry
- Non-HIV neurological disorders
- Epilepsy with antiepileptic treatment
- Untreated hepatitis C virus infection
- Current CNS or systemic malignant tumors or opportunistic infections
- History of treated CNS or systemic malignancy or opportunistic infection within 5 years
- Recent treatment or diagnosis of syphilis or neurosyphilis
- Severe chronic obstructive pulmonary disease
- Congestive heart failure
- Daily systemic steroid use (except testosterone)
- Diseases causing bleeding disorders
- Use of immunostimulant therapies or investigational ARV medications within 30 days
- Use of immunosuppressive medications affecting study outcomes
- Pregnancy, breastfeeding, or planning pregnancy during study
- Allergies to study drugs
- Use of prohibited medications at screening
- For lumbar puncture sub-study: anticoagulant use, intracerebral mass or lesions, active CNS infection, lidocaine allergy, inability to tolerate lumbar puncture, BMI over 40 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Alabama CRS
Birmingham, Alabama, United States, 35222
Actively Recruiting
2
University of California, Los Angeles CARE Center CRS
Los Angeles, California, United States, 90035
Actively Recruiting
3
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
Actively Recruiting
4
University of California, San Francisco HIV/AIDS CRS
San Francisco, California, United States, 94110
Actively Recruiting
5
Harbor University of California, Los Angeles Center CRS
Torrance, California, United States, 90502
Actively Recruiting
6
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Whitman-Walker Institute, Inc. CRS
Washington D.C., District of Columbia, United States, 20009
Actively Recruiting
8
The Ponce de Leon Center CRS
Atlanta, Georgia, United States, 30308-2012
Actively Recruiting
9
Northwestern University CRS
Chicago, Illinois, United States, 60611
Not Yet Recruiting
10
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
12
New Jersey Medical School Clinical Research Center CRS (Site ID 31786)
Newark, New Jersey, United States, 07103
Actively Recruiting
13
Weill Cornell Chelsea CRS
New York, New York, United States, 10010
Not Yet Recruiting
14
Columbia Physicians & Surgeons (P&S) CRS
New York, New York, United States, 10032
Not Yet Recruiting
15
Weill Cornell Uptown CRS
New York, New York, United States, 10065
Not Yet Recruiting
16
University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, United States, 14642
Not Yet Recruiting
17
Chapel Hill CRS
Chapel Hill, North Carolina, United States, 27599-7215
Actively Recruiting
18
Greensboro CRS
Greensboro, North Carolina, United States, 27401-1020
Actively Recruiting
19
Cincinnati CRS
Cincinnati, Ohio, United States, 45267-0405
Actively Recruiting
20
Case CRS
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
21
Ohio State University CRS
Columbus, Ohio, United States, 43210
Actively Recruiting
22
Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
23
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
24
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States, 37204
Not Yet Recruiting
25
Houston Advancing Research Team CRS
Houston, Texas, United States, 77030
Not Yet Recruiting
26
Gaborone CRS
Gaborone, Botswana
Not Yet Recruiting
27
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil, 21040-900
Not Yet Recruiting
28
Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, Maharashtra, India, 411001
Not Yet Recruiting
29
Moi University Clinical Research Center (MUCRC) CRS
Eldoret, Rift Valley, Kenya, 30100
Not Yet Recruiting
30
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
Kericho, Rift Valley, Kenya, 20200
Not Yet Recruiting
31
Blantyre CRS
Blantyre, Malawi, 265
Not Yet Recruiting
32
Nutrición-Mexico CRS
Mexico City, Tlalpan, Mexico, 14080
Not Yet Recruiting
33
Barranco CRS
Lima, Peru, 15063
Not Yet Recruiting
34
De La Salle Medical and Health Sciences Institute - Angelo King Medical Research Center (DLSMHSI-AKMRC)
Dasmariñas, Cavite, Philippines, 4114
Not Yet Recruiting
35
Durban International CRS
Mount Edgecombe, South Africa, 4302
Not Yet Recruiting
36
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Pathum Wan, Bangkok, Thailand, 10330
Not Yet Recruiting
37
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, Thailand, 50200
Not Yet Recruiting
38
Joint Clinical Research Centre (JCRC)/Kampala CRS
Kampala, Uganda
Not Yet Recruiting
39
Hanoi Medical University (HMU)
Hanoi, Vietnam, 10000
Not Yet Recruiting
40
Milton Park CRS
Milton Park, Harare, Zimbabwe
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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