Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

Exclusion Criteria36

• Active suicidality, and/or severe MDD, psychotic disorders, manic or hypomanic symptoms occurring in the context of bipolar disorder type I or II, or cyclothymic disorder, or another current Axis I diagnosis judged by the investigator to interfere with the trial.
• Study candidate self-report of depressive symptoms that have persisted for over 50 percent of waking hours and for over 50 percent of days over the 24 months prior to study entry.
• 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.
• Any acute infection within 14 days prior to study entry.
• Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry.
• Active coronary artery disease (CAD) or myocardial infarction (MI) within 180 days prior to study entry.
• Presence of rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus (SLE), dermatomyositis, ulcerative colitis, Crohn's disease, or other chronic inflammatory conditions.
• Immune reconstitution inflammatory syndrome (IRIS) or a history of IRIS within 180 days prior to study entry.
• Unstable or advanced liver disease.
• Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function within 30 days prior to study entry.
• Non-HIV-associated neurological disorder comorbidity.
• Diagnosis of epilepsy with antiepileptic drug treatment.
• Untreated HCV infection and HCV viremia.
• Current CNS malignant tumor or CNS opportunistic infection (OI).
• Current systemic malignant tumor or of a current systemic AIDS-defining OI.
• History of completed treatment of CNS or systemic malignant tumor within the 5 years prior to study entry.
• History of completed treatment of CNS OI within the 5 years prior to study entry.
• Documented history of completed treatment of systemic AIDS-defining OI, as well as Mycobacterium Tuberculosis Infection, within the 180 days prior to study entry.
• New diagnosis of syphilis or treatment for syphilis within the 180 days prior to study entry.
• History of neurosyphilis.
• Severe chronic obstructive pulmonary disease.
• Congestive heart failure (CHF).
• Use of systemic steroids daily (except testosterone).
• Diseases that cause a known bleeding diathesis.
• Immunostimulant therapies and trials of non-FDA-approved ARV medications within 30 days prior to study entry.
• Immunosuppressive medications if judged by the investigator to affect study outcomes.
• Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding.
• Known allergy/sensitivity or any hypersensitivity to the study drugs or their formulations.
• Study candidates on prohibited medications at the time of screening will be excluded from study participation.
• Current use of anti-coagulants.
• Known presence of intracerebral mass or lesion that is judged to affect the safety of an LP.
• Known presence of an active CNS infection that could alter CNS/CSF inflammatory measures.
• Known allergy to lidocaine.
• Individuals who are unable to safely tolerate an LP due to physical limitation or condition.
• Body mass index (BMI) greater than 40 kg/m\^2.