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New treatment option for Human Immunodeficiency Virus
Official title Low Dose Naltrexone for Pain in Patients With HIV
ClinicalTrials.gov ID: NCT05537935
What this study is testing
What is Low Dose Naltrexone?
Low Dose Naltrexone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for human immunodeficiency virus.
Also referred to as Questionnaires.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Diagnosis of neuropathic pain (pain that is associated with a lesion or disease involving the somatosensory nervous system, e.g., painful neuropathy...
- 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
You likely can't join if
- Allergy to naltrexone (not applicable to the control group)
- Current use of any opioids, up to 10 days before the start of the study (not applicable to the control group)
- Pregnant women
- Nursing mothers and women of childbearing potential not using contraception known to be highly effective (not applicable for the control group)...
- Use of oral, injected, or implanted hormonal methods of contraception or;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
See the full eligibility criteria
- 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...
- 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...
- 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
- Allergy to naltrexone (not applicable to the control group)
- Current use of any opioids, up to 10 days before the start of the study (not applicable to the control group)
- 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...
- 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.
- Bipolar disorder, schizophrenia, poorly controlled anxiety or depression
- Diagnosis of liver disease, e.g. cirrhosis
- Current diagnosis of either chronic kidney disease or acute kidney injury and/or a GFR \<45 at baseline
- 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
- People who may require opioid therapy during the duration of the study, e.g. upcoming surgery
- Transportation issues interfering with return study visits (NA for the control group)
- Adults unable to consent
- Prisoners
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.