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RecruitingChronic Widespread Pain

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Eligible age

19–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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

Sponsor: Florida International University

You may qualify if…

  • 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

You may not qualify if…

  • 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

Where it's recruiting

Florida

Miami

Source: ClinicalTrials.gov · NCT04787848 · last updated 2026-01-14

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics · TrialPath