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NCT04401917 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of Neuroinflammation FNOS PET/CT in HIV (+) and (-) Subjects With OUD and Healthy Controls
A Early Phase 1 study of HIV Infections and Opioid Use, sponsored by University of Pennsylvania.
- Active
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT04401917: Active Early Phase 1 study of HIV Infections and Opioid Use, sponsored by University of Pennsylvania.
NCT04401917 is a Early Phase 1 study of HIV Infections and Opioid Use that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 26 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401917, a Early Phase 1 study of HIV Infections and Opioid Use, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive tracer called \[18F\]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will see how the tracer is taken up in the brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Participants will undergo approximately 60 minutes of dynamic scanning of the brain starting at approximately the time of injection of \[18F\]NOS. Participants are required to have a brain MRI performed within 1 year prior to study enrollment, or if the subject has not had a brain MRI that is deemed acceptable for use for this study they will be asked to undergo a research brain MRI after they have consented for this study.
Primary Outcome
comparing the patterns of \[18F\]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan. Comparing the whole brain \[18F\]NOS DVR response using a two-way ANCOVA. The primary factors in the model will be two two-level factors, one indicating presence/absence of OUD, and the other presence/absence of HIV.
Conditions Studied
Interventions
- DRUG [18F]NOS
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2026-12-07 |
| Phase | Early Phase 1 |
What the registry record for NCT04401917 still lists
NCT04401917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which [18F]NOS is the first listed.
NCT04401917 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04401917 about?
NCT04401917 is a clinical study titled "Evaluation of Neuroinflammation FNOS PET/CT in HIV (+) and (-) Subjects With OUD and Healthy Controls". The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive tracer called \[18F\]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will ...
What is the current status of trial NCT04401917?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2020-12-07. Estimated completion is 2026-12-07.
What conditions does trial NCT04401917 study?
This clinical trial studies the following conditions: HIV Infections, Opioid Use.
What interventions are being tested in trial NCT04401917?
The interventions under investigation include: [18F]NOS (DRUG).
Who is sponsoring clinical trial NCT04401917?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04401917 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04401917's enrollment target sits among peer trials
26 457th of 542 higher than 83 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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