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

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.

Conditions

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

Interventions

DRUG

Methadone

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.

DRUG

Buprenorphine/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.

DRUG

XR-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.

Sponsors & Collaborators

• National Institute of Drug Abuse

  collaborator FED

• The Wistar Institute

  collaborator OTHER

• Institute of Applied Medicine and Epidemiology (IMEA)

  collaborator UNKNOWN

• Ho Chi Minh City CDC

  collaborator OTHER_GOV

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Luis J Montaner, DVM, D.Phil · The Wistar Institute

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-30

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Drug

Yes

Countries

• United States
• Vietnam

Study Locations