Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

NCT04787848 | Recruiting

• 1 other identifier: 300007004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Widespread Pain

Outcome Measures

Primary Outcomes (2)

• Quantitative sensory testing (QST)

  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

  At baseline (study visit 1)

• Quantitative sensory testing (QST)

  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

  Study visit 2 will occur at least 5-7 days after the first visit

Secondary Outcomes (3)

• McGill Pain Questionnaire-Short Form

  At baseline (study visit 1)

• McGill Pain Questionnaire-Short Form

  Study visit 2 will occur at least 5-7 days after the first visit

• Measuring endogenous opioid peptides in plasma and peripheral leukocytes

  At baseline (study visit 1)

Study Arms (4)

HIV negative without chronic widespread pain

EXPERIMENTAL

50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.

Drug: Relistor Injectable Product

HIV negative with chronic widespread pain

EXPERIMENTAL

50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.

Drug: Relistor Injectable Product

HIV positive without chronic widespread pain

EXPERIMENTAL

50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.

Drug: Relistor Injectable Product

HIV positive with chronic widespread pain

EXPERIMENTAL

50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-\<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.

Drug: Relistor Injectable Product

Interventions

Relistor Injectable Product DRUG

Relistor is a peripherally acting opioid receptor antagonist approved by the FDA for relief of opioid-induced constipation

Also known as: Methylnaltrexone Bromide

HIV negative with chronic widespread pain; HIV negative without chronic widespread pain; HIV positive with chronic widespread pain; HIV positive without chronic widespread pain

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• A history of clinically significant surgery in the past year
• 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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Ambulatory Care Center, Florida International University

Miami, Florida, 33199, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Saurabh Aggarwal, MD., PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saurabh Aggarwal, MD., PhD

CONTACT

305-348-9634; saaggarw@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in the Department of Cellular and Molecular Biology

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 9, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)