Recruiting

Chronic PainChronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

Sponsor:

Florida International University

Code:

NCT04787848

Conditions

Chronic Widespread Pain

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Accepted

Interventions

Relistor Injectable Product

Study Details

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

Study ID

NCT04787848

Start date

Nov 15, 2021

Status verified date

Jan, 2026

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Accepted

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 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: HIV negative without chronic widespread pain

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.

experimental: HIV negative with chronic widespread pain

experimental: HIV positive without chronic widespread pain

experimental: HIV positive with chronic widespread pain

Interventions

Relistor Injectable Product

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

Primary outcome measure

Quantitative sensory testing (QST) [ Time Frame: At baseline (study visit 1) ]
Quantitative sensory testing (QST) [ Time Frame: Study visit 2 will occur at least 5-7 days after the first visit ]

Central Contacts and Locations

Central contacts

Saurabh Aggarwal, MD., PhD

305-348-9634 saaggarw@fiu.edu

Locations

Ambulatory Care Center, Florida International University

Recruiting

Miami, Florida, United States, 33199

Contacts

Amarilys Fernandez

305-919-4193 amtfern@fiu.edu

Principal Investigator:

Saurabh Aggarwal, MD., PhD

More Information

Sponsor

Florida International University

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida International University on 2026-01-14.