HIV/AIDS Mental and Behavioural Disorders
Conditions
Interventions
Pramipexole
Escitalopram
Sponsors
National Institute of Allergy and Infectious Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented and confirmed HIV-1, 2. Individuals age =18 to =70 years at randomization. 3. Diagnosis of MDD (by DSM-5-TR criteria) [American Psychiatric Association 2022]. 4. On current ART regimen for at least 90 days prior to study entry with no interruption in treatment (e.g., missed doses) >7 consecutive days. 5. No plans to change ART while on study. 6. Plasma HIV-1 RNA levels of 7.5 g/dL • Platelet count =40,000/mm3, Sodium level of 130-148 mEQ/L, Potassium level of 3.0-5.5 mmol/L, • Magnesium level of 1.7-2.2 mg/dL • Aspartate aminotransferase (AST) <5.0 x ULN, • Alanine aminotransferase (ALT) <5.0 x ULN, • Alkaline phosphatase =5.0 x ULN, • Estimated glomerular filtration rate (GFR) =60 mL/min/1.73 m2, • CPK <92 U/L for women and <308 U/L for men, • TSH level of 0.5 to 5.0 mlU/L, 10. Ability and willingness to provide informed consent. 11. Ability and willingness to take oral study medications. 12. Ability and willingness to undergo NP testing. 13.Those of child-bearing potential and have not undergone surgical sterilization must have a negative serum or urine pregnancy test performed at screening and within 2 days prior to study entry. 14. On highly effective methods of Contraception.
Exclusion criteria
Exclusion criteria: 1. 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 as likely to affect study outcomes or to interfere with adherence to the study protocol. 2. 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. 3. Severe, active alcohol or substance use disorder by DSM-5-TR criteria in the 6 months prior to study entry. 4. Active alcohol or substance use 5. Any acute infection within 14 days prior to study entry. 6. Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry. 7. Active coronary artery disease (CAD) or myocardial infarction (MI) within 180 days prior to study entry. 8. Presence of rheumatoid arthritis, Sjogren’s syndrome, systemic lupus erythematosus (SLE), dermatomyositis, ulcerative colitis, Crohn’s disease, or other chronic inflammatory conditions. 9. Immune reconstitution inflammatory syndrome (IRIS) or a history of IRIS within 180 days prior to study entry. 10. Unstable or advanced liver disease 11. Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function 12. Comorbidity that could influence depression or neurocognitive function 13. Diagnosis of epilepsy with antiepileptic drug treatment. 14. Untreated HCV infection and HCV viremia. 15. Current CNS malignant tumor or CNS opportunistic infection (OI) 16. Current systemic malignant tumor or of a current systemic AIDS-defining OI. 17. History of completed treatment of CNS or systemic malignant tumor within the 5 years prior to study entry. 18. History of completed treatment of CNS OI within the 5 years prior to study entry. 19. History of completed treatment of systemic AIDS- defining OI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in BDI-II/BDI-2 total score [Beck 1996] defined as the sum of all symptom scores from baseline to 24 weeks.;Occurrence of Grade =3 AEs or Grade =2 neuropsychiatric AEs (as well as specific analyses of sleep attacks, hallucinations, and impulsive behaviors known to be associated with pramipexole) related to study treatment (as judged by the site to be treatment-related) from study treatment administration through week 24.;3. Occurrence of Grade =2 neuropsychiatric AEs related to study treatment (as judged by the site to be treatment-related) from study treatment administration through week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in MDD caseness, defined as the number of symptoms present from 0 to 9, of the symptoms of major depressive disorder from baseline to 24 weeks. The MDD caseness measure is based on the same nine MDD-defining symptoms included in the MDD diagnosis-while the BDI-II/BDI-2 measures these symptoms at an ordinal level, caseness will define them as present versus absent. The nine symptoms included are: depressed mood; loss of interest/pleasure; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feeling worthless or excessive/inappropriate guilt; decreased concentration, and thoughts of death/suicide.;interest/pleasure; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feeling worthless or excessive/inappropriate guilt; decreased concentration, and thoughts of death/suicide.;Change in NP z-score from baseline to 24 weeks as assessed through 4 composite domain scores.;Change in the MOS-HIV mental health summary functioning scale score [Wojna 2018; Wu 1991] from baseline to week 24, defined by the MOS-HIV Users Manual.;Change in the MOS cognitive functioning subscale score from baseline to week 24, defined by the MOS-HIV Users Manual.;Occurrence of Grade =3 AEs or Grade =2 neuropsychiatric AEs (regardless of relationship to study treatment) from study treatment administration through week24. Occurrence of Grade =2 neuropsychiatric AEs (regardless of relationship to study treatment) from study treatment administration through week 24. Plasma HIV-1 RNA less than 50 copies/mL at week 24. | — |
Countries
Kenya
Contacts
Public ContactHellen Ngeno
Study Coordinator
Outcome results
None listed