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Chronic Widespread Pain in HIV: Relistor Study

This study is looking into new ways to understand and treat chronic widespread pain (CWP) in people living with HIV. Researchers want to see if a decrease in natural pain-relieving substances (called endogenous opioid peptides) made by certain immune cells might be contributing to pain sensitivity in people with HIV. You might be able to join if you are 19-65 years old, have a confirmed HIV diagnosis, are a patient at the UAB 1917 HIV Clinic, and are on stable antiretroviral therapy (ART). The study will use Relistor (methylnaltrexone bromide), a medication approved to relieve opioid-induced constipation, to help understand how these natural pain-relieving substances work. Success in this study will be measured by changes in pain sensitivity using quantitative sensory testing (QST). The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 200 participants. It will test the effects of Relistor Injectable Product.
What's involved
You will have two study visits, with the second visit occurring 5-7 days after the first. During these visits, quantitative sensory testing (QST) will be performed.
Compensation
Not stated in the trial record.
Follow-up
Your pain sensitivity will be measured at baseline and again 5-7 days later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04787848

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Recruiting
NAAges 19–65InterventionalBasic science
Florida International University
~200 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:Relistor Injectable Product

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantitative sensory testing (QST)
Measured over At baseline (study visit 1)
+1 more outcome measured

Conditions

Chronic Widespread Pain

Explore related trials

Pain Amplification Syndrome

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Saurabh Aggarwal, MD., PhD · PRINCIPAL_INVESTIGATOR · Florida International University

Who to contact

Saurabh Aggarwal, MD., PhD
[email protected]
305-348-9634
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Quantitative sensory testing (QST)At baseline (study visit 1)

    Measured at baseline and 30 min post intervention to assess change in response. (0=no pain, 100=most pain) * Heat Pain - 1) A slowly increasing heat stimulus (44°C, 46°C, and 48°C) will be delivered; 2) a series of 5 heat pulses (about 2 sec) will be given and pain will be rated (0-100) * Touch Test Pain. Von Frey filament will be tapped on knee and hand and asked to rate the pain (0-100) after a single tap, and after 10 consecutive taps * Pressure Pain Threshold. A slowly increasing pressure will be applied on forearm and shoulder with a probe (Algomed) till pain is felt. Then constant pressure will be applied till the sensation first becomes painful to assess threshold in kilopascals * Combined Pressure and Cold Pain. Hand will be immersed in cold water (10°C). After 30 sec, pain intensity will be rated (0-100). Hand will be kept in cold water for another 30 sec and then the pressure pain test will be performed, and first instance of pain due to pressure will be assessed

  • Quantitative sensory testing (QST)Study visit 2 will occur at least 5-7 days after the first visit

    Measured at baseline and 30 min post intervention to assess change in response. (0=no pain, 100=most pain) * Heat Pain - 1) A slowly increasing heat stimulus (44°C, 46°C, and 48°C) will be delivered; 2) a series of 5 heat pulses (about 2 sec) will be given and pain will be rated (0-100) * Touch Test Pain. Von Frey filament will be tapped on knee and hand and asked to rate the pain (0-100) after a single tap, and after 10 consecutive taps * Pressure Pain Threshold. A slowly increasing pressure will be applied on forearm and shoulder with a probe (Algomed) till pain is felt. Then constant pressure will be applied till the sensation first becomes painful to assess threshold in kilopascals * Combined Pressure and Cold Pain. Hand will be immersed in cold water (10°C). After 30 sec, pain intensity will be rated (0-100). Hand will be kept in cold water for another 30 sec and then the pressure pain test will be performed, and first instance of pain due to pressure will be assessed