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

This is an interventional basic science trial for Opioid-use Disorder focused on measuring Opioid use disorder, HIV, Medication for Opioid Use Disorder, Antiretroviral therapy, Immune activation Read More

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 use an acceptable method of birth control (e.g., birth control pills, intrauterine device [IUD], or a double barrier method of birth control (condoms and spermicide together; or diaphragm, condom and spermicide together)

Exclusion Criteria:

• Current cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder not compatible with study procedure (assessed by the medical director of the study)
• Known neurological, cardiovascular, renal, or other significant medical disorder that is likely to impair or make the individual's participation hazardous Active Tuberculosis or other symptomatic infectious disease AIDS-defining illness
• Current cancer or other malignancies
• Advanced liver disease (FibroScan® METAVIR score F3-F4, liver elasticity more than10kPa)
• Use of immunomodulators
• Meet DSM-5 criteria for any other substance use disorder (except nicotine)
• Engagement in opiate medication treatment at baseline (methadone, buprenorphine, buprenorphine/naloxone, naltrexone)
• Pending legal charges with likely incarceration within next 6 months
• Currently participating in another clinical trial