NCT04787848

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Role of Endogenous Opioid Peptides in HIV-associated Chronic Widespread Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Florida International University · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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 synthesis/release from leukocytes in people with HIV (PWH) who self-report CWP will be explored. Leukocytes (neutrophils, monocytes/macrophages, 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.

Conditions

• Chronic Widespread Pain

Interventions

Type	Name	Description
DRUG	Relistor Injectable Product	Relistor is a peripherally acting opioid receptor antagonist approved by the FDA for relief of opioid-induced constipation

Timeline

• Start date: 2021-11-15
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2021-03-09
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States