Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from the 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 aged between 18 and 85 years
• People living with HIV-1 who are on antiretroviral therapy (HIV medication) and have a very low level of virus in their blood (less than 200 copies/mL) at the screening visit
• People who score 20 or higher on a standard depression questionnaire called the CES-D, which suggests significant depressive symptoms

Who may not be able to join:

• People for whom MRI scans are not safe or suitable, or whose initial MRI scan is too poor in quality to be usable, as determined by a radiologist
• People who have had a serious recent infection, including certain bacterial, fungal, or viral infections
• People who are pregnant or breastfeeding, have severe cognitive or intellectual impairment, or are currently incarcerated
• People currently taking the HIV medications cobicistat or ritonavir
• People considered at high risk for suicide, including those with active thoughts of suicide with a plan or intent, more than two lifetime suicide attempts, or any suicide attempt in the past six months, or people expressing thoughts of harming others that require immediate clinical attention
• People with any severe or unstable medical condition, as assessed by the treating clinician
• People whose blood pressure remains at or above 160/95 mmHg after three repeat readings at the screening visit, or who have other dangerous vital sign readings as determined by a clinician
• People with significant abnormalities found during a physical examination or heart tracing (ECG) that would interfere with taking part in the study
• People with advanced liver disease (decompensated cirrhosis), significant liver inflammation based on blood test results, or uncontrolled hepatitis B or C infection
• People with severe kidney disease (confirm with trial site for specific measurement details)
• People with a seizure disorder that requires medication to control
• People who have previously had an allergic reaction or side effects from pregnenolone (the study drug)
• People currently using certain hormone treatments, including testosterone enanthate, testosterone cypionate, or estrogen-containing preparations that significantly raise estrogen levels in the body, such as oral or skin patch forms of estrogen (other hormone treatments will be assessed case by case by the trial team)
• People currently using systemic medications that suppress the immune system, such as corticosteroids, chemotherapy, or certain targeted therapies including monoclonal antibodies and TNF-inhibitors
• People whose alcohol or other substance use is heavy enough to interfere with diagnosing depression or completing study procedures
• People with a current diagnosis of bipolar disorder
• People with a current or past diagnosis of a psychotic disorder
• People with a current or past diagnosis of schizophrenia
• People who took less than 70% of the study medication as required during the lead-in phase before being randomly assigned to a treatment group
• People who are unable to swallow pills or capsules
• People who are not able to complete neuropsychological testing in English
• People currently participating in another interventional clinical trial, with some exceptions such as lifestyle or device studies (confirm with trial site for specific circumstances)

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