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Opioid Antagonist

Relistor Injection for Chronic Pain in HIV

N/A
Recruiting
Led By Saurabh Aggarwal, MD., PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
All people living with HIV must be currently receiving stable antiretroviral therapy (ART) for inclusion in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study visit 2 will occur at least 5-7 days after the first visit
Awards & highlights

Study Summary

This trial will test if decreased release of opioids by immune cells contributes to hypersensitivity in HIV patients.

Who is the study for?
This trial is for adults aged 19-65 with HIV and chronic widespread pain, receiving stable antiretroviral therapy at the UAB 1917 Clinic. HIV-negative individuals can join if they have chronic pain or no significant pain. Exclusions include anemia, blood disorders, uncontrolled diabetes, neurological diseases, severe psychiatric issues, active infections, certain medications (excluding stable pain management drugs), recent major surgery, cognitive impairment that affects understanding of the study procedures, pregnancy, systemic rheumatic disease, cachexia or severe frailty.Check my eligibility
What is being tested?
The trial tests Relistor Injectable Product to see if it helps reduce hypersensitivity in people with HIV by affecting opioid peptides released by immune cells. It aims to understand novel mechanisms behind chronic widespread pain in these patients.See study design
What are the potential side effects?
While not specified here explicitly for Relistor (methylnaltrexone bromide), common side effects may include abdominal pain or discomforts such as bloating and gas; nausea; diarrhea; headache; dizziness; increased sweating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am HIV negative and either experience pain more than once a week for 3 months or have little to no pain.
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I am living with HIV and am on a stable ART regimen.
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I am between 19 and 65 years old.
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I am HIV positive and a patient at the UAB 1917 Clinic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study visit 2 will occur at least 5-7 days after the first visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and study visit 2 will occur at least 5-7 days after the first visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantitative sensory testing (QST)
Secondary outcome measures
McGill Pain Questionnaire-Short Form
Measuring endogenous opioid peptides in plasma and peripheral leukocytes

Trial Design

4Treatment groups
Experimental Treatment
Group I: HIV positive without chronic widespread painExperimental Treatment1 Intervention
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.
Group II: HIV positive with chronic widespread painExperimental Treatment1 Intervention
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.
Group III: HIV negative without chronic widespread painExperimental Treatment1 Intervention
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.
Group IV: HIV negative with chronic widespread painExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,573 Previous Clinical Trials
2,273,079 Total Patients Enrolled
7 Trials studying Fibromyalgia
40,342 Patients Enrolled for Fibromyalgia
Saurabh Aggarwal, MD., PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Relistor Injectable Product (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04787848 — N/A
Fibromyalgia Research Study Groups: HIV positive with chronic widespread pain, HIV negative with chronic widespread pain, HIV positive without chronic widespread pain, HIV negative without chronic widespread pain
Fibromyalgia Clinical Trial 2023: Relistor Injectable Product Highlights & Side Effects. Trial Name: NCT04787848 — N/A
Relistor Injectable Product (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04787848 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant cap for this clinical experiment?

"Indeed, clinicaltrials.gov states that this experimental medical trial is still searching for participants after it was first published on November 15th 2021 and the last time it was amended being 4th of November 2022. 200 participants have to be found at a solitary site."

Answered by AI

Are there any documented precedents of Relistor Injectable Product being trialed in a clinical setting?

"Currently, 3 clinical trials are being carried out to evaluate the effectiveness of Relistor Injectable Product. One is in Phase 3 and its sites are scattered across 6 locations with Birmingham, Alabama as the primary one."

Answered by AI

Does this medical trial offer enrollment to individuals who are older than 25?

"This medical trial is only open to adults between 19 and 65 years of age. There are 34 trials for minors and 366 studies recruiting seniors."

Answered by AI

Would I meet the criteria to participate in this research study?

"Eligible patients should suffer from chronic pain, be between 19 and 65 years old, and a total of 200 participants shall be included in the medical trial."

Answered by AI

Are there any open opportunities to participate in this research?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this medical trial, which was released on November 15th 2021, is still recruiting participants. A total of 200 individuals are being sought from one centre."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Clinical Research Unit at the University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
~70 spots leftby Jun 2025