Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People living with HIV who have been on continuous HIV treatment and have had very low levels of HIV in their blood (below 200 copies/ml) for at least 12 months, confirmed at two or more clinic visits and at screening
• People whose immune cell count (CD4+) has been above 350 cells/microliter for at least 12 months, confirmed at two or more clinic visits and at screening
• People who have been formally diagnosed with major depression (current episode) or bipolar disorder in a depressed phase, as confirmed through a structured clinical interview (SCID-V)
• People who score 10 or higher on a standard depression questionnaire called the PHQ-9
• People who have either been off all antidepressant or other psychiatric medications for at least 4 weeks (or 8 weeks for fluoxetine specifically), or have been on a stable psychiatric medication regimen for at least 4 weeks before the study baseline visit
• People who show significant loss of pleasure or interest, reflected by a score of 2 or higher on the first question of the PHQ-9
• People whose blood test shows a C-reactive protein (CRP) level of 2 mg/L or higher, indicating a certain level of inflammation
• Women of reproductive age must have a negative pregnancy blood test at study entry, and both men and women must agree to use adequate contraception throughout the study

Who may not be able to join:

• People under 18 or over 65 years of age
• People who are pregnant or breastfeeding
• People with significant abnormalities in blood counts detected at screening (such as low white blood cells, low haemoglobin, or low platelets)
• People with a history of a serious brain infection called progressive multifocal leukoencephalopathy
• People with untreated latent tuberculosis infection (screening for this will be done before entry)
• People who have taken certain immune-suppressing medications in the past 6 months, including oral steroids, certain biologic medicines (such as infliximab, adalimumab, rituximab, or similar), chemotherapy agents, or JAK inhibitor medications (confirm with trial site for the full list)
• People with a history of deep vein thrombosis (a blood clot in a deep vein)
• People with certain heart or cardiovascular conditions, including coronary artery disease, a previous heart attack, heart failure with significantly reduced heart function, or a history of stroke
• People with blood cancers such as lymphoma or leukaemia
• People who have had major surgery within 8 weeks before screening, or who will need major surgery during the study
• People with a current or very recent serious infection (within 4 weeks of randomisation), including COVID-19, bacterial, fungal, or parasitic infections
• People with active herpes simplex symptoms at the time of joining the study
• People who have had a symptomatic herpes zoster (shingles) outbreak within the past 12 weeks
• People with a history of severe or widespread shingles complications (such as affecting the eye or brain)
• People who test positive for active hepatitis B virus infection (based on specific blood test results)
• People with active hepatitis C infection (confirmed by both a positive antibody test and a positive RNA test)
• People with cirrhosis of the liver from any cause
• People with certain abnormal liver-related blood test results at screening (confirm specific values with trial site)
• People with chronic kidney disease where kidney filtering function is significantly reduced (eGFR below 40 mL/min/1.73 m²)
• People with a history of a non-mood-related psychotic disorder, active psychotic symptoms of any kind, or substance abuse or dependence within 6 months of study entry
• People who test positive for illicit drugs on a urine screen at any point during the study (marijuana is excluded from this rule)
• People assessed as having an active suicide plan, based on a specific rating scale score (HAM-D item #3 score above 3)
• People with an active eating disorder or antisocial personality disorder
• People with a history of dementia
• People using steroid-containing medications regularly or taking minocycline within 2 weeks of the baseline visit or at any time during the study
• People for whom MRI scanning is not safe or suitable
• People who have not responded to more than 2 antidepressant treatments (each lasting at least 6 weeks at the recommended dose) during the current episode, or more than 5 antidepressant treatments across their lifetime
• People with a BMI over 42, or those who may not be able to fit in an MRI scanner as assessed by the investigator

Important: Always verify eligibility with the trial site directly before applying.