National Institute of Allergy and Infectious Diseases (NIAID)
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.
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…
Tablets self-administered orally
Tablets self-administered orally