Impact of Opioid Use Disorder Medications on HIV Treatment Outcomes
Effects of Mu-opiate Receptor Engagement on Microbial Translocation and Residual Immune Activation in HIV-infected, ART Suppressed Opioid Use Disorder Patients Initiating Medication-assisted Treatment
This study tests whether using medications for opioid addiction, like methadone or buprenorphine, helps people with HIV who inject drugs improve their immune health while they start HIV treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | cART |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT04480554 on ClinicalTrials.gov |
What this trial studies
This study investigates how long-term use of medications for opioid use disorder, such as methadone and buprenorphine, affects immune recovery in individuals with HIV-1 infection who also inject opioids. It aims to understand the relationship between opioid receptor stimulation and immune activation in HIV-infected people who inject drugs. Participants will be randomized to receive either methadone, buprenorphine/naloxone, or extended-release naltrexone while starting combined antiretroviral therapy (cART). The study will measure immune reconstitution and inflammation levels to provide insights into optimal treatment strategies for this population.
Who should consider this trial
Good fit: Ideal candidates include individuals with moderate to severe opioid use disorder, documented HIV-1 infection, and specific CD4 and viral load criteria.
Not a fit: Patients who do not have opioid use disorder or those with stable HIV on effective antiretroviral therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for HIV-infected individuals with opioid use disorder, enhancing their immune recovery and overall health outcomes.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated that opioid use can negatively impact immune recovery in HIV-infected individuals, suggesting a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet DSM-5 criteria for moderate to severe opiate use disorder (as determined by DSM-5 checklist) * Opiate use with a positive urine drug screen for heroin or other opiates (other than methadone, buprenorphine, buprenorphine/naloxone) at screening visit * Documented HIV-1 infection with CD4 less than 350 cells/ μL and VL more than 10,000 copies/mL * cART-naïve or or on cART no longer than 3 months if already started * Willingness to receive cART or on cART no longer than 3 months if already started * Willingness to be randomized to either daily methadone, buprenorphine/naloxone or monthly injection of extended-release naltrexone treatment * Ability to understand and complete study procedures * Provision of adequate locator information that lists all contact information a participant agrees that the research staff may use to reach him/her * All participants must be able to comprehend the purpose of the study and to provide informed consent * Is, in the opinion of the study physician, in stable health as determined by pre-study physical examination, medical history, ECG, and laboratory evaluations and is likely to complete the study. * Has a total body weight of more than 50 kg (110 pounds) and a body mass index (BMI) of more than 20 at screening. * Female subjects: Cannot be pregnant, Cannot be lactating, Must be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal defined as 1 year without bleeding or spotting) OR must agree to use an acceptable method of birth control (e.g., birth control pills, intrauterine device \[IUD\], or a double barrier method of birth control (condoms and spermicide together; or diaphragm, condom and spermicide together) Exclusion Criteria: * Current cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder not compatible with study procedure (assessed by the medical director of the study) * Known neurological, cardiovascular, renal, or other significant medical disorder that is likely to impair or make the individual's participation hazardous Active Tuberculosis or other symptomatic infectious disease AIDS-defining illness * Current cancer or other malignancies * Advanced liver disease (FibroScan® METAVIR score F3-F4, liver elasticity more than10kPa) * Use of immunomodulators * Meet DSM-5 criteria for any other substance use disorder (except nicotine) * Engagement in opiate medication treatment at baseline (methadone, buprenorphine, buprenorphine/naloxone, naltrexone) * Pending legal charges with likely incarceration within next 6 months * Currently participating in another clinical trial
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Active_not_recruiting)
- Go Vap Clinic — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Principal investigator: Luis J Montaner, DVM, D.Phil — The Wistar Institute
- Study coordinator: David S Metzger, PhD
- Email: dsm@pennmedicine.upenn.edu
- Phone: 2157467346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.