Pramipexole vs Escitalopram for Depression in HIV

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Karl Goodkin, MD, PhD

Principal Investigator

Neuropsychiatrist Consultant

Eligibility Criteria

This trial is for individuals with HIV who are experiencing major depressive disorder (MDD) and may also have mild neurocognitive disorder (MND). Specific eligibility criteria details were not provided, so interested participants should inquire further to determine if they qualify.

Inclusion Criteria

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

I have been on my current HIV treatment for at least 90 days without a break longer than a week.

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Exclusion Criteria

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

I have an active hepatitis C infection that hasn't been treated.

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Treatment Details

Interventions

Escitalopram (Other)
Pramipexole ER (Other)

Trial OverviewThe study compares the safety and effectiveness of two medications: Pramipexole ER, a drug often used for Parkinson's disease, against Escitalopram, a common antidepressant. It aims to see which is better for treating depression in people with HIV.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm 2: EscitalopramExperimental Treatment1 Intervention

Group II: Arm 1: Pramipexole ERExperimental Treatment1 Intervention

Escitalopram is already approved in Canada for the following indications: