NCT05537935RecruitingPhase 4
Low Dose Naltrexone for Pain in Patients With HIV
Low Dose Naltrexone (LDN) for the Treatment of Chronic Neuropathic Pain in Patients With Human Immunodeficiency Virus (HIV), a Prospective, Pragmatic, Open Label Clinical Trial
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Sept 2022
- Start date
- 28 Apr 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Emory University
- Diseases
- HIV
- NCT number
- NCT05537935
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 28 Apr 2023 to the primary completion date, 30 Jun 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of any opioids, up to 10 days before the start of the study (not applicable to the control group)
- People who may require opioid therapy during the duration of the study, e.g. upcoming surgery
Other illness
- Allergy to naltrexone (not applicable to the control group)
- Bipolar disorder, schizophrenia, poorly controlled anxiety or depression
- Diagnosis of liver disease, e.g. cirrhosis
- Acute viral hepatitis A, B, C
- Patients who self-report as having tested positive for COVID-19 or have been diagnosed with another viral illness within the past ten days.
- Patients with a known or suspected diagnosis of long-term COVID
- Active drug or alcohol use disorder
Lab values
- Current diagnosis of either chronic kidney disease or acute kidney injury and/or a GFR \<45 at baseline
Other
- Pregnant women
- Nursing mothers and women of childbearing potential not using contraception known to be highly effective (not applicable for the control group). Highly effective contraception methods include a combination of any two of the following during the 12-week study period:
- Use of oral, injected, or implanted hormonal methods of contraception or;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical /vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;
- Total abstinence;
- Male/female sterilization.
- Transportation issues interfering with return study visits (NA for the control group)
- Adults unable to consent
- Prisoners
Who the study is looking for
- Age 18-75, male and female
- HIV infection with a viral load of \< 1000 copies/ml for the past 12 months. (That is the viral load below which, according to the 2018 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, there is no thought of a significant risk of HIV transmission from the mother to the fetus with vaginal delivery. This was thought to be a reasonable cut-off for inclusion in this study.)
- Diagnosis of neuropathic pain (pain that is associated with a lesion or disease involving the somatosensory nervous system, e.g., painful neuropathy, radicular pain, complex regional pain syndrome, nerve-related pain following spine surgery, etc.) using the neuropathic pain screening tool, painDETECT17, as part of the neuropathic pain screen.
- Pain score \> 4/10 on average on the NPRS lasting \> 3 months (chronic pain)
- Capable of informed consent and willing to comply with the study requirements
- Fluent English-speaking
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grady Memorial Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Midtown Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.