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Corticosteroid
Hydrocortisone for HIV (Human Immunodeficiency Virus) (MsSCORE Trial)
Phase < 1
Waitlist Available
Led By Leah Rubin
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and 28 days
Awards & highlights
Summary
This trial will study a new intervention for cognitive impairment in HIV-infected women, which targets the mechanisms by which stress negatively affects cognitive functioning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline and 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hopkins Verbal Learning Test-Revised assesses total learning
Hopkins Verbal Learning Test-Revised assesses verbal memory
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Line Orientation Task assesses visuospatial abilities
+1 moreSecondary outcome measures
Comalli Stroop Test, Trial 1 assesses processing speed/attention
Comalli Stroop Test, Trial 2 assesses processing speed/attention
Comalli Stroop Test, Trial 3 assesses behavioral inhibition
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydrocortisoneExperimental Treatment1 Intervention
Low dose hydrocortisone (10mg orally)
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablets, made of starch 1500 powder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
2005
Completed Phase 4
~1280
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,285 Previous Clinical Trials
14,842,929 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,683 Total Patients Enrolled
Leah RubinPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious head injury where you were unconscious for more than 1 hour.You have had a problem with drugs or alcohol in the past six months.You have high levels of stress or have been diagnosed with a mood or anxiety disorder.You are currently taking steroids on a regular basis.You have high blood pressure or diabetes that is not being treated right now.You have a history of dementia, any other neurological disorder affecting the brain and nervous system, or a disorder related to AIDS.You have a history of schizophrenia or a condition called schizoaffective disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Hydrocortisone
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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