Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Last updated: February 15, 2025
Sponsor: Florida International University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Fibromyalgia

Pain

Treatment

Relistor Injectable Product

Clinical Study ID

NCT04787848
300007004
  • Ages 19-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed HIV diagnosis and currently a patient in the UAB 1917 HIV Clinic

  • Age 19 - 65; the lower end of this age range was chosen to capture young adults withHIV infection, and participants over 65 years are increasingly likely to meet one ormore exclusion criteria

  • All people living with HIV must be currently receiving stable antiretroviral therapy (ART) for inclusion in this study

  • Non-HIV participants must be confirmed as HIV negative. HIV-negative participantswith chronic widespread pain must self-report bodily pain more than once per weekfor at least three consecutive months and HIV-negative participants without chronicpain must self-report no pain, or pain less frequently than once per week for atleast three consecutive months

Exclusion

Exclusion Criteria:

  • Anemia

  • Current or past history of blood disorders which may increase hemolysis

  • Active microbial infections which may alter the quantity or quality of bloodinflammatory cells such as monocytes and neutrophils

  • Use of certain medication other than antiretroviral therapy that might conflict withstudy observations. However, participants will not be excluded or asked to withdrawfrom medications used for pain management since temporary withdrawal from thesemedications could affect pain measures (exceptions will be therapies such asmethadone or buprenorphine used to treat opioid addiction). Only those who arestable on these medications for at least 60 days will be included. All patientmedications used for at least the 60 days prior to participation will be recordedand controlled in statistical analyses as needed

  • Systemic rheumatic disease (e.g., rheumatoid arthritis, systemic lupuserythematosus). These rheumatologic conditions will be excluded due to theirautoimmune characteristic. . Cachexia (wasting syndrome) and severe frailty. Thisexclusion is in place to protect against the stress of experimental pain testing

  • A history of clinically significant surgery in the past year

  • Uncontrolled hypertension (i.e. SBP/DBP of >150/95) or cardiovascular or peripheralarterial disease. These exclusions are in place primarily for safety reasons becausethe cold pressor task represents a cardiovascular challenge. However, uncontrolledhypertension can also affect pain perception, which is another reason for excludingthese individuals

  • Poorly controlled diabetes (HbA1c > 8%) for both safety reasons, and becausediabetic neuropathy could alter pain perception

  • Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy)

  • Serious psychiatric disorder requiring hospitalization within the past 12 months orcharacterized by active suicidal ideation

  • Any participant deemed to be actively suicidal upon study screening will be escortedto the UAB emergency room and evaluated by the Psychiatry Service

  • Diminished cognitive function that would interfere with understanding of studyprocedures. The Realm Health Literacy Test will be administered to ensure thatparticipants are free of cognitive impairment that would compromise studyparticipation

  • Pregnancy. Inclusion/exclusion criteria will be verified using the screening tool incombination with review of participants' medical records

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Relistor Injectable Product
Phase:
Study Start date:
November 15, 2021
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Clinical Research Unit at the University of Alabama at Birmingham

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Ambulatory Care Center, Florida International University

    Miami, Florida 33199
    United States

    Active - Recruiting

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