ACTG A5402: 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

Treatment Experienced

A5402 is a phase II, open-label, randomized clinical trial comparing the efficacy and safety of two medications (pramipexole versus escitalopram) for treating major depressive disorder (MDD), including with mild neurocognitive disorder (MND), in persons with HIV (PWH) over 24 weeks. The study will also look at any effect on activities of daily living.

Why is this study being done?

 

• To compare the effect of pramipexole to escitalopram in the treatment of MDD (and MDD with MND)
• To evaluate the safety of pramipexole and escitalopram in PWH having MDD (and MDD with MND)
• To assess the impact on activities of daily living

 

• Living with HIV, 18-70 years old
• Confirmation of major depressive disorder, including decreased functional status
• No other current interfering psychiatric diagnosis
• Able to complete neuropsychological tests
• On stable treatment for HIV for at least 3 months with undetectable HIV viral load
• Not currently taking antidepressants

 

What do I need to do in the study?

 

Participants will be randomized 1:1 to either pramipexole extended-release (ER) or escitalopram, taken by mouth daily for 24 weeks.

 

Participants will have physical and mental status examinations, blood tests, urine tests, and will complete questionnaires. For participants at US sites, there is an optional substudy that requires lumbar punctures. Participants will be in this study for approximately 24 weeks.

 

Pramipexole extended-release (ER) and escitalopram will be provided by the study. The dose will be gradually increased to week 6 (by participant tolerance) and continue through week 24.

 

Participants will be in this study for approximately 24 weeks.