RecruitingPhase 2NCT04480554

Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

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

Sponsor

University of Pennsylvania

Enrollment

225 participants

Start Date

Jan 30, 2023

Study Type

INTERVENTIONAL

Conditions

Inflammation HIV-1-infection Opioid-use Disorder Antiretroviral Treatment Immune Activation Methadone Buprenorphine Naltrexone

Summary

HIV infection, as well as exposure to opioids (including heroin), are associated with systemic immune activation including increased microbial translocation from the gut. The overall objective of this study is to define the impact of long-term mu-opiate receptor stimulation or blockage with medication for opiate use disorder (i.e, methadone, buprenorphine/naloxone, or extended-release naltrexone) on the kinetics and extent of immune reconstitution on HIV-1 infected people who inject opiate and initiating antiretroviral therapy.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the best way to treat people who have both HIV and opioid addiction at the same time. It compares three medications for opioid use disorder — methadone, buprenorphine/naloxone, and extended-release naltrexone — to see which works best alongside HIV treatment. **You may be eligible if...** - You have moderate-to-severe opioid use disorder with a positive urine drug screen - You have documented HIV infection with a low immune cell count (CD4 under 350) and high viral load - You have not yet started HIV treatment, or started recently (within 3 months) - You are willing to be assigned to one of the three opioid treatment options **You may NOT be eligible if...** - You are already well-established on HIV treatment - You are not willing to participate in randomized treatment assignment - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethadone

Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone syrup (MET), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy.

DRUGBuprenorphine/naloxone

Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine/naloxone tablets (Suboxone(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy.

DRUGXR-Naltrexone

Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy.