RECRUITING

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

Talk to us

Conditions

Opioid-use DisorderHIV-1-infectionImmune ActivationInflammationMethadoneBuprenorphineNaltrexoneAntiretroviral TreatmentOpioid use disorderHIVMedication for Opioid Use DisorderAntiretroviral therapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of Mu-opiate Receptor Engagement on Microbial Translocation and Residual Immune Activation in HIV-infected, ART Suppressed Opioid Use Disorder Patients Initiating Medication-assisted Treatment

Quick Facts

Study Start:2023-01-30
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04480554

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meet DSM-5 criteria for moderate to severe opiate use disorder (as determined by DSM-5 checklist)
  2. * Opiate use with a positive urine drug screen for heroin or other opiates (other than methadone, buprenorphine, buprenorphine/naloxone) at screening visit
  3. * Documented HIV-1 infection with CD4 less than 350 cells/ μL and VL more than 10,000 copies/mL
  4. * cART-naïve or or on cART no longer than 3 months if already started
  5. * Willingness to receive cART or on cART no longer than 3 months if already started
  6. * Willingness to be randomized to either daily methadone, buprenorphine/naloxone or monthly injection of extended-release naltrexone treatment
  7. * Ability to understand and complete study procedures
  8. * Provision of adequate locator information that lists all contact information a participant agrees that the research staff may use to reach him/her
  9. * All participants must be able to comprehend the purpose of the study and to provide informed consent
  10. * 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.
  11. * Has a total body weight of more than 50 kg (110 pounds) and a body mass index (BMI) of more than 20 at screening.
  12. * 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)
  1. * Current cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder not compatible with study procedure (assessed by the medical director of the study)
  2. * 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
  3. * Current cancer or other malignancies
  4. * Advanced liver disease (FibroScan® METAVIR score F3-F4, liver elasticity more than10kPa)
  5. * Use of immunomodulators
  6. * Meet DSM-5 criteria for any other substance use disorder (except nicotine)
  7. * Engagement in opiate medication treatment at baseline (methadone, buprenorphine, buprenorphine/naloxone, naltrexone)
  8. * Pending legal charges with likely incarceration within next 6 months
  9. * Currently participating in another clinical trial

Contacts and Locations

Study Contact

David S Metzger, PhD
CONTACT
2157467346
dsm@pennmedicine.upenn.edu
Cecile M Denis, PhD
CONTACT
2158981825
cdenis@pennmedicine.upenn.edu

Principal Investigator

Luis J Montaner, DVM, D.Phil
PRINCIPAL_INVESTIGATOR
The Wistar Institute

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Luis J Montaner, DVM, D.Phil, PRINCIPAL_INVESTIGATOR, The Wistar Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-30
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-01-30
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Opioid use disorder
  • HIV
  • Medication for Opioid Use Disorder
  • Antiretroviral therapy
  • Immune activation

Additional Relevant MeSH Terms

  • Opioid-use Disorder
  • HIV-1-infection
  • Immune Activation
  • Inflammation
  • Methadone
  • Buprenorphine
  • Naltrexone
  • Antiretroviral Treatment