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

Ki vehet részt

• 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 8 weeks prior to study entry
• 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
• Study candidates of child-bearing potential who are participating in sexual activity that could lead to pregnancy must agree to use at least one highly effective method for contraception
• Non-focal neurological examination. Study candidates with focal findings should have expert assessment for mass effect prior to the LP
• Laboratory values that meet LP protocol criteria as determined by the site investigator

Ki nem vehet részt

• 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
• 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
• Immune reconstitution inflammatory syndrome (IRIS) or a history of IRIS within 180 days prior to study entry
• Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function within 30 days prior to study entry
• 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
• Use of systemic steroids daily (except testosterone)
• 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
• Study candidates on prohibited medications at the time of screening will be excluded from study participation
• 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
• Presence of rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus (SLE), dermatomyositis, ulcerative colitis, Crohn's disease, or other chronic inflammatory conditions
• Unstable or advanced liver disease
• 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 neurosyphilis
• Severe chronic obstructive pulmonary disease
• Congestive heart failure (CHF)
• Diseases that cause a known bleeding diathesis
• Known allergy/sensitivity or any hypersensitivity to the study drugs or their formulations
• 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
• Active alcohol or substance use judged by the investigator to interfere with the trial
• Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
• Current use of anti-coagulants
• Known presence of intracerebral mass or lesion that is judged to affect the safety of an LP
• Body mass index (BMI) greater than 40 kg/m\^2