Relistor Injection for Chronic Pain in HIV
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen bySaurabh Aggarwal, MD., PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Florida International University
Must be taking: Antiretroviral therapy
Must not be taking: Methadone, Buprenorphine
Disqualifiers: Anemia, Blood disorders, Infections, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?To determine if decreased production or release of endogenous opioid peptides by peripheral immune cells contributes to hypersensitivity in people with HIV
Will I have to stop taking my current medications?
The trial does not require participants to stop taking their current medications for pain management, as long as they have been stable on them for at least 60 days. However, medications like methadone or buprenorphine used for opioid addiction treatment may be exceptions.
What data supports the effectiveness of the drug Relistor Injection for chronic pain in HIV patients?
There is no direct evidence from the provided research articles about the effectiveness of Relistor Injection for chronic pain in HIV patients. However, the use of opioid treatments like buprenorphine has been shown to be effective and safe for pain management in HIV patients, suggesting that similar treatments might offer some benefits.
12345How is the drug Relistor Injection unique for treating chronic pain in HIV?
Relistor Injection (Methylnaltrexone) is unique because it is specifically designed to treat opioid-induced constipation without affecting pain relief, which can be particularly beneficial for people with HIV who are on long-term opioid therapy for chronic pain. Unlike other treatments that may affect the central nervous system, Relistor works peripherally, meaning it targets the gut to relieve constipation without crossing into the brain, thus not interfering with pain management.
12678Eligibility Criteria
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.Inclusion Criteria
I am HIV negative and either experience pain more than once a week for 3 months or have little to no pain.
I am living with HIV and am on a stable ART regimen.
I am between 19 and 65 years old.
+1 more
Exclusion Criteria
You have a serious mental illness that needed hospital treatment or have been thinking about hurting yourself.
I do not have high blood pressure or heart/blood vessel diseases.
Any participant deemed to be actively suicidal upon study screening will be escorted to the UAB emergency room and evaluated by the Psychiatry Service
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Quantitative sensory testing (QST) and blood samples are collected to measure endogenous opioid peptides
1 day
1 visit (in-person)
Treatment
Participants are randomly administered saline or RELISTOR and undergo quantitative sensory testing
2 visits
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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.
Relistor Injectable Product is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Relistor for:
- Opioid-induced constipation (OIC) in adults with chronic non-cancer pain
- OIC in adults with advanced illness or pain caused by active cancer
🇨🇦 Approved in Canada as Relistor for:
- Opioid-induced constipation (OIC) in adults with chronic non-cancer pain
- OIC in adults with advanced illness or pain caused by active cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ambulatory Care Center, Florida International UniversityMiami, FL
Clinical Research Unit at the University of Alabama at BirminghamBirmingham, AL
Loading ...
Who Is Running the Clinical Trial?
Florida International UniversityLead Sponsor
University of Alabama at BirminghamLead Sponsor
References
Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial. [2020]Untreated opioid addiction in people with HIV is associated with poor HIV treatment outcomes. Slow-release, long-acting, implantable naltrexone might improve these outcomes. Here, we present results of a study aimed to test this hypothesis.
Brief Report: The Association of Chronic Pain and Long-Term Opioid Therapy With HIV Treatment Outcomes. [2022]Chronic pain occurs in up to 85% of persons living with HIV and is commonly treated with long-term opioid therapy (LTOT). We investigated the impact of chronic pain and LTOT on HIV outcomes.
Safety and efficacy of transdermal buprenorphine and transdermal fentanyl in the treatment of neuropathic pain in AIDS patients. [2022]Multifactor neuropathic pain is one of the most frequent symptoms in AIDS patients and analgesic treatment is primarily based on the use of drug combination of opioids, tricyclic antidepressants and antiepileptics. However, the chronic use of opioids in AIDS patients presents a risk due to the immunosuppressive action of these drugs. Until now, buprenorphine has been regarded as one of the safest opioid analgesics for the treatment of patients with compromised immune systems. To assess the suitability of transdermal fentanyl for the treatment of neuropathic pain in AIDS patients, the present study compares the efficacy, tolerability and the immunosuppressive effects of transdermal buprenorphine vs. fentanyl.
Inadequate treatment of pain in ambulatory HIV patients. [2019]To evaluate the prevalence of pain, how pain affects patients' lives, what treatments are being used, and the effectiveness of these pain treatments in ambulatory patients with human immunodeficiency virus (HIV) disease.
A trial of integrated buprenorphine/naloxone and HIV clinical care. [2013]Untreated opioid dependence adversely affects the care of human immunodeficiency virus (HIV)-positive patients. Buprenorphine, a partial opioid agonist, is available for maintenance treatment of opioid dependence in HIV specialty settings. We investigated the feasibility and efficacy of integrating buprenorphine, along with 2 levels of counseling, into HIV clinical care.
Morphine/naltrexone. [2021]Oral morphine/naltrexone extended release capsules comprise the selective mu-opioid receptor agonist morphine in a sustained-release formulation combined with a sequestered core of the mu-opioid receptor antagonist naltrexone for use in the management of moderate to severe pain. When morphine/naltrexone is taken as intended, naltrexone exerts no clinically significant effect. However, when the capsule contents are taken after being tampered with by crushing, chewing or dissolution, naltrexone is rapidly released and absorbed, thereby mitigating the effects of morphine. Morphine/naltrexone was effective in the treatment and management of moderate to severe chronic pain in patients with pain due to osteoarthritis of the hip or knee participating in a randomized, double-blind, placebo-controlled, phase III study (n = 344). Changes in mean Brief Pain Inventory (BPI) average scores from baseline of the double-blind maintenance phase to 12 weeks were significantly better with morphine/naltrexone (20 mg/0.8 mg to 80 mg/3.2 mg twice daily) than with placebo. In a 12-month, open-label safety study, morphine/naltrexone also provided effective pain relief and sustained pain control in patients with chronic, moderate to severe, nonmalignant pain (n = 465 at baseline; 162 at study end). Furthermore, significant mean changes from baseline in BPI worst, least, average and current pain scores were seen from week 1 onwards. Morphine/naltrexone treatment was generally well tolerated in adult patients with chronic moderate to severe nonmalignant pain in clinical trials of up to 1-year duration.
Buprenorphine TDS: use in daily practice, benefits for patients. [2022]In Germany and many other countries, buprenorphine has been used for a long time for the management of pain in both cancer and non-cancer patients. Although a transdermal delivery system for buprenorphine (Transtec) has recently been introduced, the clinical experience in daily practice with this drug, delivered in a matrix patch, is only now being evaluated. In preliminary data from a survey of 3,255 patients with chronic pain, 26% had cancer pain, while the most common diagnoses of the other respondents included back pain (33%), osteoarthritis (22%), osteoporosis (17%), and neuropathic pain (10%, multiple entries). Before being switched to the buprenorphine patch, most patients had been pretreated with World Health Organization (WHO) Step II opioids (47%) or WHO Step III opioids (18%), including tramadol (in 35% of patients) and a tilidin/naloxone combination (15%); 9% had not been prescribed any opioids in advance of receiving transdermal buprenorphine. Most patients (77%) in the survey had been started on the lowest dose of the buprenorphine patch (35 microg/h), and nearly half (49%) were placed on adjuvant analgesics, including tramadol or tilidin/naloxone. Pain relief was rated as good or very good by 81% of the respondents. Adverse effects were similar to those seen on other opioids, although their intensity was mild in most cases. Local side effects, including erythema (4% of cases) and pruritus (1%), were transitory. Based on the survey results, transdermal buprenorphine is considered an effective opioid treatment for patients with stable cancer and non-cancer pain; it may prove particularly useful in patients who have experienced side effects taking oral analgesic preparations, as well as in those who are taking extensive co-medications.
[Transdermal buprenorphine: a current overview of pharmacological and clinical data]. [2015]Our understanding of the pathophysiologic mechanisms of chronic pain progresses; the complexity of the problem justifies our need for new molecules and new ways of administration that will help to further optimise and better individualize our pharmacologic therapies. Whereas acute pain can be considered an alarm signal, chronic pain constitutes, per se, a syndrome that requires a meticulous selection of the analgesic drug(s). Since pain is permanent, the continuous administration of the analgesic is recommended rather than an on demand administration. Transdermic modes of administration are of value for the treatment of chronic pain because they allow a progressive delivery of the active compound together with the maintenance of stable plasma levels of the drug. Buprenorphine is a semi-synthetic opioid that is available in the sublingual, injectable, or transdermic forms. The matrix patch of buprenorphine represents a major asset for the treatment of chronic pain, whether it be cancerous in origin, or not. Its efficacy and safety have been clearly demonstrated in randomised double blind trials as well as in post-marketing surveillance observations. Buprenorphine, administered as a transdermal therapeutic system, induces a dose-related pain relief, whatever the nature of the pain and the age of the patient. Buprenorphine also exerts an analgesic action on neuropathic pain. It differs from other opioids by its affinity as a partial agonist on mu and kappa receptors, and as a complete agonist of ORL-1 receptors. Therefore, transdermal buprenorphine will be useful to all physicians having to control severe pain by powerful opioids.