Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics (NCT04787848) | Clinical Trial Compass
RecruitingNot Applicable
Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics
United States200 participantsStarted 2021-11-15
Plain-language summary
To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV
Who can participate
Age range19 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
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 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 …
What they're measuring
1
Quantitative sensory testing (QST)
Timeframe: At baseline (study visit 1)
2
Quantitative sensory testing (QST)
Timeframe: Study visit 2 will occur at least 5-7 days after the first visit