Effects of Glucocorticoids on Cognition in HIV-infected Women
NCT03237689, Early phase 1, Completed, Johns Hopkins University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Glucocorticoids on Cognition in HIV-infected Women | ClinicalTrials.gov |
| NCT number | NCT03237689 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Early phase 1 | ClinicalTrials.gov |
| Enrollment | 136 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Conditions | Hiv | ClinicalTrials.gov |
| Interventions | Hydrocortisone, Placebo Oral Tablet | ClinicalTrials.gov |
| First posted | 2017-08-02 | ClinicalTrials.gov |
| Last updated | 2023-09-29 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hopkins Verbal Learning Test-Revised assesses total learning | change between baseline and 28 days | a 12-item list-learning task across 3 trials used to measure total learning. Outcome=total learning across trials (range 0-36). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Primary | Hopkins Verbal Learning Test-Revised assesses verbal memory | change between baseline and 28 days | following the 3 learning trials there is a 20-25 minute delay. After the delay, participants are asked to recall as many words as they can from the initial learning list. Outcome=delayed free recall (range 0-12).Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Primary | Wechsler Adult Intelligence Scale IV Letter-Number Sequencing assesses working memory condition | change between baseline and 28 days | participants hear a series of letters and numbers, and then recite them back in ascending order, with the numbers first and then the letters. Outcome=total correct (range 0-24). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Primary | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Line Orientation Task assesses visuospatial abilities | change between baseline and 28 days | In each of 10 trials, a visual array of 13 lines fans out from a common point of origin. Two target lines are shown beneath each array, and participants must identify the lines within the array that match each of the two target lines. Outcome=Total correct (range=0-20). | ClinicalTrials.gov |
| Secondary | Trail Making Test Part A assesses processing speed/attention | change between baseline and 28 days | 25 circles distributed over a sheet of paper. The circles are numbered 1 - 25 and the participant should draw lines to connect the numbers in ascending order. Outcome=Time to completion (range: 10 to 300 seconds). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Secondary | Trail Making Test Part B assesses mental flexibility | change between baseline and 28 days | 25 circles are distributed over a sheet of paper. Circles include both numbers (1 - 13) and letters (A - L). The participant draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Outcome=time to completion (range: 18-300). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Secondary | Comalli Stroop Test, Trial 1 assesses processing speed/attention | change between baseline and 28 days | Participants identify aloud the colors of a series of squares. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Secondary | Comalli Stroop Test, Trial 2 assesses processing speed/attention | change between baseline and 28 days | Participants read a series of color names printed in black ink. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Secondary | Comalli Stroop Test, Trial 3 assesses behavioral inhibition | change between baseline and 28 days | Participants name the color of the ink but ignore the word. Outcome=time to completion (range: 50 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance. | ClinicalTrials.gov |
| Secondary | Liver function as assessed by aspartate aminotransferase (AST) levels | change between baseline and 28 days | levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events. | ClinicalTrials.gov |
| Secondary | Liver function as assessed by alanine transaminase (ALT) levels | change between baseline and 28 days | levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events. | ClinicalTrials.gov |
| Secondary | Liver function as assessed by alkaline phosphatase levels | change between baseline and 28 days | levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events. | ClinicalTrials.gov |
| Secondary | renal function assessed by creatinine levels | change between baseline and 28 days | levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events. | ClinicalTrials.gov |
| Secondary | metabolic function assessed by glucose levels | change between baseline and 28 days | levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events. | ClinicalTrials.gov |
| Secondary | metabolic function assessed by hemoglobin A1c (HbA1c) | change between baseline and 28 days | levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42606862 | DERIVED | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01MH113512 | Effects of Glucocorticoids on Cognitive Functioning in HIV-infected Women | RUBIN, LEAH HELANE | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2017 to 2021 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delayed Recall Module | Primary outcome | ConductCognition |
| Letter-Number Sequencing Task | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)