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

Launched by UNIVERSITY OF PENNSYLVANIA · Jul 17, 2020

Keywords

ClinConnect Summary

This clinical trial, titled "Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1," is exploring how different treatments for opioid use disorder, like methadone, buprenorphine/naloxone, and extended-release naltrexone, affect the immune system in people living with HIV. The goal is to understand how these medications influence the recovery of the immune system in individuals who inject opioids and are starting anti-HIV treatment.

To participate in this study, individuals must be between the ages of 18 and 65 and have a moderate to severe opioid use disorder, confirmed by a checklist. They should also have documented HIV-1 infection, with specific blood test results indicating their health status. Participants will receive either daily or monthly medication and will be closely monitored throughout the study. It's important to note that women who can become pregnant must either be using birth control or be unable to conceive. This study is currently recruiting participants and aims to provide valuable insights into how opioid treatments can work alongside HIV care.

Gender

ALL

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