Effects of Glucocorticoids on Cognition in HIV-infected Women

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Cortisol succinate; Glucocorticoids; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Females only;

• HIV-infected;

• Able to give informed consent;

• Able to travel to study site for study participation;

• Age between 18 and 65;

• English as a first language;

• Above-average self-reported levels of perceived stress (>14 on the perceived stress scale (PSS-10)) and/or current SCID-V diagnosis of mood and/or anxiety disorder;

• Meet criteria for HIV-associated cognitive dysfunction (based on Neurocognitive test battery and instrumental activities of daily living assessment-impairment on only 1 cognitive domain is required)

• Virally suppressed and on combination antiretroviral therapy (Plasma HIV RNA<1000cp/ml and bring in medications)

Exclusion Criteria:

• Current use of hormone-based contraceptives (birth control pills or patch);

• Currently pregnant, post-partum or lactating;

• Currently regular use of steroids;

• History of closed head injury resulting in loss of consciousness greater than 1 hour;

• History of schizophrenia or schizoaffective disorder;

• Current untreated hypertension or diabetes*;

• History of dementia or any other neurologic central nervous system (CNS) or AIDS-defining disorder;

• Positive urine toxicology screen (except marijuana) or breathalyzer and/or any evidence of acute intoxication or withdrawal.

• History of substance abuse/dependence in the past six months.

Participants who present with a heretofore untreated condition (e.g., hypertension) will be excluded; however, they may be rescreened for eligibility after receiving appropriate treatment for the condition in the course of their standard medical care (at least 6 months).