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NCT05537935 · ClinicalTrials.gov registry record · Phase 4
Low Dose Naltrexone for Pain in Patients With HIV
A Phase 4 study of Human Immunodeficiency Virus and Chronic Neuropathic Pain, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT05537935: Recruiting Phase 4 study of Human Immunodeficiency Virus and Chronic Neuropathic Pain, sponsored by Emory University.
NCT05537935 is a Phase 4 study of Human Immunodeficiency Virus and Chronic Neuropathic Pain that is actively recruiting participants, run by Emory University. The registered enrollment target is 60 participants, below the 182-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (67% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05537935, a Phase 4 study of Human Immunodeficiency Virus and Chronic Neuropathic Pain, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The increased life expectancy of Patients Living With HIV/AIDS (PLWHA) has increased the need for therapies for chronic conditions, such as chronic pain. Pain in the HIV population is often refractory and ends up being treated with chronic opioids, which are associated with adverse effects, including hyperalgesia, constipation, and risk of overdose. Naltrexone is an opioid antagonist used in the treatment of alcohol and opioid use disorders. Low Dose Naltrexone (LDN), naltrexone at a much lower dose, is thought to be an immune modulator and has been associated with an increased CD4 count in PLWHA. Repurposing this medication is relatively inexpensive and has the potential to expand access to treatment for a painful condition experienced in PLWHA. While there are many case reports on the efficacy of LDN in symptom reduction, there are only a small number of clinical trials that specifically examine pain and symptom relief. This study will include patients who are not completely virologically controlled and will monitor the CD4 counts drawn as a part of routine care. If the CD4 count improves with LDN and with reduced symptoms, this could be a significant improvement in HIV therapy for symptom control. There have been studies showing cytokine reduction in fibromyalgia patients but they did not investigate the correlation with cytokines and pain relief. This study involves repurposing a drug used for substance use disorder to a medication with the potential to treat pain and improve symptoms for PLWHA.
Primary Outcome
The study team will give participants a link to the online PROMIS questionnaire that includes a numerical pain rating scale (NPRS) to complete using an iPad or computer and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire and NPRS to complete for future visits. The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an el
Conditions Studied
Interventions
- DRUG Low Dose Naltrexone
Study Locations (3)
Georgia
- Grady Memorial Hospital - Atlanta
- Emory Midtown Hospital - Atlanta
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-04-28 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT05537935 shows while recruiting
NCT05537935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 182-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention - of which Low Dose Naltrexone is the first listed.
NCT05537935 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05537935 about?
NCT05537935 is a clinical study titled "Low Dose Naltrexone for Pain in Patients With HIV". The increased life expectancy of Patients Living With HIV/AIDS (PLWHA) has increased the need for therapies for chronic conditions, such as chronic pain. Pain in the HIV population is often refractory and ends up being treated with chronic opioids, which are associated with adverse effects, includin...
What is the current status of trial NCT05537935?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2023-04-28. Estimated completion is 2026-12.
What conditions does trial NCT05537935 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus, Chronic Neuropathic Pain.
What interventions are being tested in trial NCT05537935?
The interventions under investigation include: Low Dose Naltrexone (DRUG).
Who is sponsoring clinical trial NCT05537935?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05537935 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05537935's enrollment target sits among peer trials
60 21st of 39 higher than 19 of 39 other Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
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