RECRUITING

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-11-15

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04787848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 with HIV infection, and participants over 65 years are increasingly likely to meet one or more 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 participants with chronic widespread pain must self-report bodily pain more than once per week for at least three consecutive months and HIV-negative participants without chronic pain must self-report no pain, or pain less frequently than once per week for at least three consecutive months	* Anemia * Current or past history of blood disorders which may increase hemolysis * Active microbial infections which may alter the quantity or quality of blood inflammatory cells such as monocytes and neutrophils * Use of certain medication other than antiretroviral therapy that might conflict with study observations. However, participants will not be excluded or asked to withdraw from medications used for pain management since temporary withdrawal from these medications could affect pain measures (exceptions will be therapies such as methadone or buprenorphine used to treat opioid addiction). Only those who are stable on these medications for at least 60 days will be included. All patient medications used for at least the 60 days prior to participation will be recorded and controlled in statistical analyses as needed * Systemic rheumatic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus). These rheumatologic conditions will be excluded due to their autoimmune characteristic. . Cachexia (wasting syndrome) and severe frailty. This exclusion 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 peripheral arterial disease. These exclusions are in place primarily for safety reasons because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals * Poorly controlled diabetes (HbA1c \> 8%) for both safety reasons, and because diabetic neuropathy could alter pain perception * Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy) * Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation * Any participant deemed to be actively suicidal upon study screening will be escorted to the UAB emergency room and evaluated by the Psychiatry Service * Diminished cognitive function that would interfere with understanding of study procedures. The Realm Health Literacy Test will be administered to ensure that participants are free of cognitive impairment that would compromise study participation * Pregnancy. Inclusion/exclusion criteria will be verified using the screening tool in combination with review of participants' medical records

Inclusion Criteria

Exclusion 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 with HIV infection, and participants over 65 years are increasingly likely to meet one or more 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 participants with chronic widespread pain must self-report bodily pain more than once per week for at least three consecutive months and HIV-negative participants without chronic pain must self-report no pain, or pain less frequently than once per week for at least three consecutive months

* Anemia
* Current or past history of blood disorders which may increase hemolysis
* Active microbial infections which may alter the quantity or quality of blood inflammatory cells such as monocytes and neutrophils
* Use of certain medication other than antiretroviral therapy that might conflict with study observations. However, participants will not be excluded or asked to withdraw from medications used for pain management since temporary withdrawal from these medications could affect pain measures (exceptions will be therapies such as methadone or buprenorphine used to treat opioid addiction). Only those who are stable on these medications for at least 60 days will be included. All patient medications used for at least the 60 days prior to participation will be recorded and controlled in statistical analyses as needed
* Systemic rheumatic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus). These rheumatologic conditions will be excluded due to their autoimmune characteristic. . Cachexia (wasting syndrome) and severe frailty. This exclusion 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 peripheral arterial disease. These exclusions are in place primarily for safety reasons because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals
* Poorly controlled diabetes (HbA1c \> 8%) for both safety reasons, and because diabetic neuropathy could alter pain perception
* Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy)
* Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation
* Any participant deemed to be actively suicidal upon study screening will be escorted to the UAB emergency room and evaluated by the Psychiatry Service
* Diminished cognitive function that would interfere with understanding of study procedures. The Realm Health Literacy Test will be administered to ensure that participants are free of cognitive impairment that would compromise study participation
* Pregnancy. Inclusion/exclusion criteria will be verified using the screening tool in combination with review of participants' medical records

Contacts and Locations

Study Contact

Saurabh Aggarwal, MD., PhD

CONTACT

205-996-7134

saurabhaggarwal@uabmc.edu

Principal Investigator

Saurabh Aggarwal, MD., PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

Clinical Research Unit at the University of Alabama at Birmingham

Birmingham, Alabama, 35205

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Saurabh Aggarwal, MD., PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-15

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-11-15

Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

Chronic Widespread Pain