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

Inclusion Criteria12

• 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)