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New treatment option for Chronic Widespread Pain
Official title Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics
ClinicalTrials.gov ID: NCT04787848
What this study is testing
What is Relistor Injectable Product?
Relistor Injectable Product is an investigational medicine, being studied as a potential treatment for chronic widespread pain.
Also referred to as Methylnaltrexone Bromide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 65. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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...
- Pregnancy. Inclusion/exclusion criteria will be verified using the screening tool in combination with review of participants' medical records
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.