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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

All people living with HIV must be currently receiving stable antiretroviral therapy (ART) for inclusion in this study

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

Must not have

Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy)

Poorly controlled diabetes (HbA1c > 8%) for both safety reasons, and because diabetic neuropathy could alter pain perception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study visit 2 will occur at least 5-7 days after the first visit

Awards & highlights

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like Parkinson's, MS, or epilepsy.

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My diabetes is not well-managed (HbA1c over 8%).

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I have anemia.

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I have a history of blood disorders that could increase cell breakdown.

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I do not have any active infections that could affect my blood's immune cells.

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I have had major surgery within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study visit 2 will occur at least 5-7 days after the first visit

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quantitative sensory testing (QST)

Secondary study objectives

McGill Pain Questionnaire-Short Form

Measuring endogenous opioid peptides in plasma and peripheral leukocytes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Group III: HIV negative without chronic widespread painExperimental Treatment1 Intervention

Group IV: HIV negative with chronic widespread painExperimental Treatment1 Intervention

0 / 9Eligibility criteria met