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Funding not renewed
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| Name | Class |
|---|---|
| National Institute of Drug Abuse | FED |
| The Wistar Institute | OTHER |
| Institute of Applied Medicine and Epidemiology (IMEA) | UNKNOWN |
| Ho Chi Minh City CDC |
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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.
The use of intravenous opioids (e.g., heroin) has been shown to impair the immune reconstitution outcomes of combined antiretroviral therapy (cART) in HIV-1-infected individuals. People who inject opioid drugs (PWID) have lower CD4 count recovery and sustained cellular activation and inflammation compared to non-opioid users. The pathogenesis of this phenomenon remains understudied. Notably, the effect of oral μ-opioid receptor (MOR) full agonists (e.g., methadone) or partial agonist (e.g., buprenorphine), which are widely used as medications for opioid use disorder treatment, on cART-mediated immune reconstitution is also unknown, limiting the information available to healthcare providers on immune or viral outcomes associated with MOR agonists or antagonists (e.g., naltrexone) in HIV-infected PWIDs. The primary objective of this proposal is to establish the extent and pathogenesis of residual immune activation/inflammation, levels of immune reconstitution, and HIV measures in HIV-1-infected PWID who start cART concomitant with medication for opioid use disorder in an addiction clinic with three strategies: a) integrated treatment program (ITP) with oral methadone maintenance, or b) ITP with oral buprenorphine, or c) ITP with extended-release naltrexone.
The primary hypothesis is that PWIDs receiving MOR agonists (i.e. methadone maintenance) will have impaired cART-mediated immune reconstitution outcomes and/or higher levels of systemic immune activation and cell-associated HIV as compared to PWIDs receiving MOR partial agonist (i.e., buprenorphine/naloxone) or antagonist (i.e., extended-release naltrexone).
The investigators will test these hypotheses in the following specific aims:
Specific Aim 1: To define the impact of sustained MOR stimulation on the kinetics and extent of immune reconstitution and activation in HIV-1-infected PWID who are starting cART. To this end, the investigators will compare long-term changes in immune activation and senescence, systemic inflammation, and biological immune reconstitution parameters in a cohort of PWID with chronic HIV infection initiating ART, randomized 1:1:1 to either methadone, buprenorphine/naloxone or extended-release naltrexone.
Specific Aim 2: To define the clinical and virological correlates of long-term treatment with MOR full agonist (methadone), partial agonist (buprenorphine/naloxone) and antagonist (extended-release naltrexone), by analysis of clinical outcomes (CD4 count), adherence to ART, and retention in care. Viral measures will focus on the changes in persistent HIV reservoir measures on ART (i.e., characterization of cell-associated viral RNA and DNA species in PBMC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone | Experimental | 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). |
|
| Buprenorphine/naloxone | Experimental | 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). |
|
| XR-Naltrexone | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone syrup (MET), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sCD14 | Change in plasma sCD14 concentration over 24 weeks | Baseline, Week-4, -8, -12, -24 |
| Measure | Description | Time Frame |
|---|---|---|
| Marker of Immune Activation: Change in CD38 | Change in CD38 concentration over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Immune Activation: HLA-DR | Change in HLA-DR concentration over 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis J Montaner, DVM, D.Phil | The Wistar Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Go Vap Clinic |
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Participants were randomized to methadone, buprenorphine or extended-release naltrexone. Participants were allowed to switch treatment at the time of randomization if they do not want to receive the assigned treatment at randomization. Only one switch was allowed.
Participants were analyzed per treatment they have been taking.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methadone | 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). Methadone: Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone syrup (MET), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2020 |
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| OTHER_GOV |
The study will enroll 225 HIV-positive subjects who meet DSM-5 opiate use disorder criteria and who are using opiates (primarily heroin). All subjects will receive a 48-week integrated treatment program for opiate use disorder with either (randomly assigned) daily directly observed oral methadone (MET) and buprenorphine/naloxone (BUP/NX) or monthly injection extended-release naltrexone (XR-NTX).
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| Buprenorphine/naloxone | Drug | Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine/naloxone tablets (Suboxone(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|
| XR-Naltrexone | Drug | Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|
| baseline, Week-4, -8, -12, -24 |
| Marker of Immune Activation: Change in PD1 | Change in PD1 expression in C8+ T cells over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Immune Activation: Change in CD169 | Change in CD169 expression in monocytes over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Immune Activation: Change in sCD163 | Change in plasma sCD163 concentration over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Immune Activation: Change in Type-I IFN | Change in type-I IFN signature over 24 weeks | baseline, week -12, -24 |
| Marker of Inflammation: Change in Plasma Hr-CRP | Change in plasma hr-CRP concentration over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Inflammation: Change in D-dimer | Change in plasma d-dimer concentration over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Inflammation: Change in sTNFR-1 | Change in plasma sTNFR-1 concentration over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Inflammation: Change in Interleukins IL-6 and IL-10 | Change in plasma IL-6 and IL-10 concentration over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Inflammation: Change in TGF-beta | Change in plasma TGF-beta concentration over 24 weeks | baseline, Week-4, -8, -12, -24 |
| Marker of Bacterial Translocation: Change in LPB | Change in plasma LPB concentration at 24 weeks | Baseline, Week-24 |
| Marker of Bacterial Translocation: Change in LPS | Change in plasma LPS concentration at 24 weeks | Baseline, Week-24 |
| Marker of Bacterial Translocation: Change in Endo-CAB | Change in plasma endo-CAB concentration at 24 weeks | Baseline, Week-24 |
| Marker of Bacterial Translocation: Change in Intestinal Fatty Acid-binding Protein (I-FABP) | Change in plasma I-FABP concentration at 24 weeks | Baseline, Week-24 |
| Marker of Bacterial Translocation: Change in Zonulin-1 | Change in plasma Zonulin-1 concentration at 24 weeks | Baseline, Week-24 |
| Marker of Bacterial Translocation: Change in s16 rDNA | Change in s16rDNA concentration at 24 weeks | Baseline, Week-24 |
| Marker of Bacterial Translocation: Change in Bacterial Butyryl-coA-coA | Change in bacterial butyryl-coA-coA concentration at 24 weeks | Baseline, Week-24 |
| Retention in Care | Number of participants who were receiving treatment ar Week 4, 8, 12, 16, 20 and 24 | Baseline to Week-24 |
| HIV-related Outcomes: Change in CD4 Counts | Change in CD4 counts over 24 weeks | baseline, Week-4, -8, -12, -24 |
| HIV-related Outcomes: cART Adherence | Number of participants who get a ART medication at Baseline, Week 4, 8, 12, 24 | baseline, Week-4, -8, -12, -24 |
| HIV-related Clinical Outcomes: Viral Load | HIV viral load at Baseline, Week-12, and Week-24 | baseline, Week-12, -24 |
| Addiction Clinical Outcomes: Medication for Opioid Use Disorder (MOUD) | Comparison of number of participants who completed the treatment in each group | Week 24 |
| Addiction Clinical Outcomes: Change in Drug Use | Number of participants with opioid use at Baseline, Week-4, 8, 12, 16, 20, and 24 | Baseline, Week-4, -8, -12, -16, -20, -24 |
| Ho Chi Minh City |
| Vietnam |
| FG001 | Buprenorphine | 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). Buprenorphine: Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine tablets, structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
| FG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methadone | 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). Methadone: Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone syrup (MET), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
| BG001 | Buprenorphine | 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). Buprenorphine: Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine tablets, structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
| BG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in sCD14 | Change in plasma sCD14 concentration over 24 weeks | Missing data due to participants missing assessment or enable to provide blood draw at assessment | Posted | Mean | Standard Deviation | pg/ML | Baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Immune Activation: Change in CD38 | Change in CD38 concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Immune Activation: HLA-DR | Change in HLA-DR concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Immune Activation: Change in PD1 | Change in PD1 expression in C8+ T cells over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Immune Activation: Change in CD169 | Change in CD169 expression in monocytes over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Immune Activation: Change in sCD163 | Change in plasma sCD163 concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Immune Activation: Change in Type-I IFN | Change in type-I IFN signature over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, week -12, -24 |
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| Secondary | Marker of Inflammation: Change in Plasma Hr-CRP | Change in plasma hr-CRP concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Inflammation: Change in D-dimer | Change in plasma d-dimer concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Inflammation: Change in sTNFR-1 | Change in plasma sTNFR-1 concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Inflammation: Change in Interleukins IL-6 and IL-10 | Change in plasma IL-6 and IL-10 concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Inflammation: Change in TGF-beta | Change in plasma TGF-beta concentration over 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | baseline, Week-4, -8, -12, -24 |
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| Secondary | Marker of Bacterial Translocation: Change in LPB | Change in plasma LPB concentration at 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | Baseline, Week-24 |
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| Secondary | Marker of Bacterial Translocation: Change in LPS | Change in plasma LPS concentration at 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | Baseline, Week-24 |
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| Secondary | Marker of Bacterial Translocation: Change in Endo-CAB | Change in plasma endo-CAB concentration at 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | Baseline, Week-24 |
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| Secondary | Marker of Bacterial Translocation: Change in Intestinal Fatty Acid-binding Protein (I-FABP) | Change in plasma I-FABP concentration at 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | Baseline, Week-24 |
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| Secondary | Marker of Bacterial Translocation: Change in Zonulin-1 | Change in plasma Zonulin-1 concentration at 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | Baseline, Week-24 |
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| Secondary | Marker of Bacterial Translocation: Change in s16 rDNA | Change in s16rDNA concentration at 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | Baseline, Week-24 |
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| Secondary | Marker of Bacterial Translocation: Change in Bacterial Butyryl-coA-coA | Change in bacterial butyryl-coA-coA concentration at 24 weeks | As an international study, the study has been early terminated by the federal government. The samples have been collected but because of the early termination, we have a lack of funding and are unable to conduct this analysis. There are no results for this outcome. Samples will not be analyzed at a later time. | Posted | Baseline, Week-24 |
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| Secondary | Retention in Care | Number of participants who were receiving treatment ar Week 4, 8, 12, 16, 20 and 24 | Posted | Number | participants | Baseline to Week-24 |
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| Secondary | HIV-related Outcomes: Change in CD4 Counts | Change in CD4 counts over 24 weeks | Missing data as participants missed some assessment points or unable to collect blood at the time of the assessment | Posted | Mean | Standard Deviation | cells/µL | baseline, Week-4, -8, -12, -24 |
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| Secondary | HIV-related Outcomes: cART Adherence | Number of participants who get a ART medication at Baseline, Week 4, 8, 12, 24 | Missing data due to participants dropping off the study | Posted | Count of Participants | Participants | baseline, Week-4, -8, -12, -24 |
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| Secondary | HIV-related Clinical Outcomes: Viral Load | HIV viral load at Baseline, Week-12, and Week-24 | Missing values due to participants missing the assessment or unable to collect blood at the time of assessment | Posted | Mean | Standard Deviation | copies/µL | baseline, Week-12, -24 |
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| Secondary | Addiction Clinical Outcomes: Medication for Opioid Use Disorder (MOUD) | Comparison of number of participants who completed the treatment in each group | Drop out of participants | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Addiction Clinical Outcomes: Change in Drug Use | Number of participants with opioid use at Baseline, Week-4, 8, 12, 16, 20, and 24 | Percentage of opioid user among participants who have completed the time-point assessment | Posted | Count of Participants | Participants | Baseline, Week-4, -8, -12, -16, -20, -24 |
|
All adverse events occurring during the study period (Baseline to 48 weeks follow-up) with a severity grade of 2 or higher are recorded.
Adverse events that occur at any point in the trial are identified, managed, and documented.
The relationship of each adverse event to the study procedures is characterized. PIs and medical coordinator classify the AEs/ SAEs as definitely related, probably related, possibly related, unlikely or unrelated to the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methadone | 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). Methadone: Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone syrup (MET), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. | 0 | 29 | 1 | 29 | 1 | 29 |
| EG001 | Buprenorphine | 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). Buprenorphine/naloxone: Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine tablet, structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. | 1 | 27 | 1 | 27 | 0 | 27 |
| EG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. | 0 | 22 | 1 | 22 | 5 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral fungal infection | Infections and infestations | Systematic Assessment | Infection attributable to HIV and low CD4 count. |
| |
| Death | General disorders | Systematic Assessment | Hospital discharge document reported the following diagnoses: joint pain, shoulder osteoarthritis, gastroesophageal reflux. Participant died at home. The cause of death in unknown. |
| |
| Hip surgery | Surgical and medical procedures | Systematic Assessment | Participant reported pain on right artificial hip. Orthopedic diagnosed a "looseness of the artificial hip". Surgery was conducted and participant fully recovered without sequalae. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia | General disorders | Systematic Assessment |
| ||
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Elevated AST/ALT | Hepatobiliary disorders | Systematic Assessment |
| ||
| Skin infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecile Denis, PhD | University of Pennsylvania | 215-898-0607 | cdenis@pennmedicine.upenn.edu |
| Jun 30, 2020 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008691 | Methadone |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| C000624616 | vivitrol |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Week 4 |
|
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| Week 8 |
|
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| Week 12 |
|
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| Week 24 |
|
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
| OG002 | XR-Naltrexone | 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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|
|
| XR-Naltrexone |
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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|
| XR-Naltrexone |
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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|
| XR-Naltrexone |
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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|
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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|
| OG002 |
| XR-Naltrexone |
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). XR-Naltrexone: Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy. |
|
|