Inflammation Clinical Trial
— AMOHI-1Official 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
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.
Status | Recruiting |
Enrollment | 225 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Vietnam | Go Vap Clinic | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Ho Chi Minh City CDC, Institute of Applied Medicine and Epidemiology (IMEA), National Institute of Drug Abuse, The Wistar Institute |
United States, Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in sCD14 | Change in plasma sCD14 concentration over 48 weeks | Baseline, Week-4, -8, -12, -24, -36, -48 | |
Secondary | Marker of immune activation: Change in CD38 | Change in CD38 concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -36 and -48 | |
Secondary | Marker of immune activation: HLA-DR | Change in HLA-DR concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -36 and -48 | |
Secondary | Marker of immune activation: Change in PD1 | Change in PD1 expression in C8+ T cells over 48 weeks | baseline, Week-4, -8, -12, -24, -36 and -48 | |
Secondary | Marker of immune activation: Change in CD169 | Change in CD169 expression in monocytes over 48 weeks | baseline, Week-4, -8, -12, -24, -36 and -48 | |
Secondary | Marker of immune activation: Change in sCD163 | Change in plasma sCD163 concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -36 and -48 | |
Secondary | Marker of immune activation: Change in Type-I IFN | Change in type-I IFN signature over 48 weeks | baseline, week -12, -24, -36 and -48 | |
Secondary | Marker of inflammation: Change in Plasma hr-CRP | Change in plasma hr-CRP concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -48 | |
Secondary | Marker of inflammation: Change in d-dimer | Change in plasma d-dimer concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -48 | |
Secondary | Marker of inflammation: Change in sTNFR-1 | Change in plasma sTNFR-1 concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -48 | |
Secondary | Marker of inflammation: Change in Interleukins IL-6 and IL-10 | Change in plasma IL-6 and IL-10 concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -48 | |
Secondary | Marker of inflammation: Change in TGF-beta | Change in plasma TGF-beta concentration over 48 weeks | baseline, Week-4, -8, -12, -24, -48 | |
Secondary | Marker of bacterial translocation: Change in LPB | Change in plasma LPB concentration at 48 weeks | Baseline, Week-48 | |
Secondary | Marker of bacterial translocation: Change in LPS | Change in plasma LPS concentration at 48 weeks | Baseline, Week-48 | |
Secondary | Marker of bacterial translocation: Change in endo-CAB | Change in plasma endo-CAB concentration at 48 weeks | Baseline, Week-48 | |
Secondary | Marker of bacterial translocation: Change in Intestinal fatty acid-binding protein (I-FABP) | Change in plasma I-FABP concentration at 48 weeks | Baseline, Week-48 | |
Secondary | Marker of bacterial translocation: Change in Zonulin-1 | Change in plasma Zonulin-1 concentration at 48 weeks | Baseline, Week-48 | |
Secondary | Marker of bacterial translocation: Change in s16 rDNA | Change in s16rDNA concentration at 48 weeks | Baseline, Week-48 | |
Secondary | Marker of bacterial translocation: Change in bacterial butyryl-coA-coA | Change in bacterial butyryl-coA-coA concentration at 48 weeks | Baseline, Week-48 | |
Secondary | Retention in care | Percentage of completed medication visits over 48 weeks | Baseline to Week-48 | |
Secondary | HIV-related outcomes: Change in CD4 counts | Change in CD4 counts over 48 weeks | baseline, Week-4, -8, -12, -24, -36 and -48 | |
Secondary | HIV-related outcomes: cART adherence | Number of prescription refills over 48-weeks | baseline, Week-4, -8, -12, -24, -36 and -48 | |
Secondary | HIV-related clinical outcomes: Viral load | Percentage of participants with a suppressed viral load at Week-12, -24, and -48 | baseline, Week-12, -24, and -48 | |
Secondary | Addiction clinical outcomes: Medication for opioid use disorder (MOUD) | Comparison of percentage of participants who completed the treatment in each group | Week 48 | |
Secondary | Addiction clinical outcomes: Change in Drug use | Change in percentage of monthly drug use over 48 weeks | Baseline, Week-4, -8, -12, -16, -20, -24, -28, -32, -36, -40, -44, and -48 |
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