Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787848
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2021-02-25
Brief Title:
Chronic Widespread Pain in HIV Novel Mechanisms and Therapeutics
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Role of Endogenous Opioid Peptides in HIV-associated Chronic Widespread Pain
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV
Detailed Description:
The prevalence of chronic widespread pain CWP in individuals infected with the human immunodeficiency virus HIV-1 includes regional and widespread musculoskeletal pain of neuropathic and inflammatory nature HIV-related CWP leads to 10x greater odds of functional impairment However the specific mechanisms that contribute to CWP in HIV are not understood Thus pharmacological and non-pharmacological approaches to mitigate CWP have had minimal benefits contributing to an overreliance on opioids and alarming rise in addiction and overdose The overall objective of this study is to address the gap in the knowledge of the pathogenesis of HIV-related CWP Specifically the role of impaired endogenous opioid synthesisrelease from leukocytes in people with HIV PWH who self-report CWP will be explored Leukocytes neutrophils monocytesmacrophages and lymphocytes are a rich source of opioid peptides Met-enkephalin dynorphin A β-endorphin that inhibit nociception by binding to peripheral opioid receptors Therefore to establish whether decreased peripheral opioid peptides correlate with experimental pain measures in PWH with self-reported CWP quantitative sensory testing QST will be completed before and after administration of methylnaltrexone bromide RELISTOR a clinically available peripherally acting opioid receptor antagonist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None