ClinicalTrials.gov ID:NCT06705478

Brief Summary

A5402, also known as COPE, is 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: COPE

Detailed Description
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).

PWH between 18 and 70 years, who have a diagnosis of MDD alone or with comorbid MDD and MND with HIV-1 RNA  < 200 copies/mL within 90 days prior to randomization will be enrolled.  Once enrolled, Participants will be randomized 1:1 to therapeutically escalating doses of Pramipexole ER or Escitalopram.  Study drug administration will be for 28 days.

Participants will be assessed comprehensively at baseline and Week 24. They will be briefly assessed at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional substudy to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of up to 36 participants.