Phase 4 HIV and AIDS Trial, Recruiting NCT05537935 Sponsor: Emory University Condition: HIV and AIDS
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Phase 4 HIV and AIDS Trial, Recruiting

NCT05537935
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between 18 and 75 years old, of any gender
  • People living with HIV whose virus levels in the blood have stayed below 1,000 copies/ml for the past 12 months
  • People who have been diagnosed with nerve-related pain (such as painful nerve damage, radiating pain, complex regional pain syndrome, or nerve pain after spine surgery), confirmed using a specific pain screening tool used in this study
  • People whose pain levels average more than 4 out of 10 and have lasted longer than 3 months
  • People who are able to understand and agree to the study requirements
  • People who speak fluent English

Who may not be able to join:

  • People with a known allergy to the medication naltrexone (this does not apply to the control group)
  • People who have used opioid medications within the 10 days before the study starts (this does not apply to the control group)
  • People who are currently pregnant
  • People who are breastfeeding, or people of childbearing potential who are not using two highly effective forms of contraception throughout the 12-week study — acceptable methods include hormonal contraception, an intrauterine device (IUD/IUS), barrier methods with spermicide, total abstinence, or sterilisation (this does not apply to the control group)
  • People with a diagnosis of bipolar disorder, schizophrenia, or poorly controlled anxiety or depression
  • People with a diagnosis of liver disease, such as cirrhosis
  • People with chronic or acute kidney disease, or whose kidney function falls below a certain level at the start of the study (confirm with trial site)
  • People with an active hepatitis A, B, or C infection
  • People who have recently tested positive for COVID-19 or been diagnosed with another viral illness within the past 10 days
  • People with a known or suspected diagnosis of long COVID
  • People with an active drug or alcohol use disorder
  • People who are likely to need opioid medications during the study period, for example due to planned surgery
  • People who have transport difficulties that would prevent them from attending follow-up study visits (this does not apply to the control group)
  • People who are not able to provide informed consent
  • People who are currently imprisoned

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Anne M McKenzie-Brown, MD, Emory University

Phone: 404-686-2410

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
28 April 2023
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Changes in Numerical Pain Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov