drugset / Trial / NCT04480554
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
Phase 2
Terminated
78 enrolled
University of Pennsylvania
Ho Chi Minh City CDC · collabInstitute of Applied Medicine and Epidemiology (IMEA) · collabNational Institute of Drug Abuse · collabThe Wistar Institute · collab
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2023-01-30
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | — | Oral |
| Subject | Methadone | Other / unclassified | — | Oral |
| Subject | Naloxone | Small molecule | — | Oral |
| Subject | Naltrexone | Small molecule | — | Other |