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

PHASE2RecruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

January 30, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Opioid-use DisorderHIV-1-infectionImmune ActivationInflammationMethadoneBuprenorphineNaltrexoneAntiretroviral 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.

Trial Locations (2)

19104

ACTIVE_NOT_RECRUITING

University of Pennsylvania, Philadelphia

Unknown

RECRUITING

Go Vap Clinic, Ho Chi Minh City

All Listed Sponsors
collaborator

National Institute of Drug Abuse

FED

collaborator

The Wistar Institute

OTHER

collaborator

Institute of Applied Medicine and Epidemiology (IMEA)

UNKNOWN

collaborator

Ho Chi Minh City CDC

OTHER_GOV

lead

University of Pennsylvania

OTHER