Status:
COMPLETED
Effects of Glucocorticoids on Cognition in HIV-infected Women
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Hiv
Eligibility:
FEMALE
18-65 years
Phase:
EARLY_PHASE1
Brief 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 wo...
Detailed Description
The overall aim of this study is to contribute important foundational knowledge of the utility of targeting neuroinflammation and the hypothalamic-pituitary-adrenal (HPA) axis to improve cognition in ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03237689
Start Date
November 20 2017
End Date
September 8 2023
Last Update
September 29 2023
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224