Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 (NCT04480554) | Clinical Trial Compass
TerminatedPhase 2
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
Stopped: Funding not renewed
United States, Vietnam78 participantsStarted 2023-01-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…