Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 (AMOHI-1)
Opioid-use Disorder, HIV-1-infection, Immune Activation
About this trial
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
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
- Go Vap ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Methadone
Buprenorphine/naloxone
XR-Naltrexone
Participants in this arm will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone (MET) and antiretroviral therapy (cART).
Participants in this arm will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine/naloxone and antiretroviral therapy (cART).
Participants in this arm will receive a 48-week integrated treatment program for opiate use disorder with monthly injection extended-release naltrexone (XR-NTX) and antiretroviral therapy (cART).