Trial Outcomes & Findings for Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 (NCT NCT04480554)
NCT ID: NCT04480554
Last Updated: 2026-04-07
Results Overview
Change in plasma sCD14 concentration over 24 weeks
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Baseline, Week-4, -8, -12, -24
Results posted on
2026-04-07
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
27
|
22
|
|
Overall Study
COMPLETED
|
14
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
15
|
21
|
15
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
3
|
|
Overall Study
06-center (mandatory closed detoxification center)
|
8
|
12
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
Move far from clinic
|
2
|
4
|
4
|
|
Overall Study
Premature termination of the study
|
2
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Participant decided to stop treatment
|
0
|
1
|
2
|
Baseline Characteristics
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
Baseline characteristics by cohort
| Measure |
Buprenorphine
n=27 Participants
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.
|
Methadone
n=29 Participants
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.
|
XR-Naltrexone
n=22 Participants
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.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=527 Participants
|
29 Participants
n=527 Participants
|
22 Participants
n=1054 Participants
|
78 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=157 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 5.2 • n=527 Participants
|
41.1 years
STANDARD_DEVIATION 6.0 • n=527 Participants
|
41.3 years
STANDARD_DEVIATION 4.4 • n=1054 Participants
|
41.7 years
STANDARD_DEVIATION 5.3 • n=157 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=527 Participants
|
3 Participants
n=527 Participants
|
5 Participants
n=1054 Participants
|
14 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=527 Participants
|
26 Participants
n=527 Participants
|
17 Participants
n=1054 Participants
|
64 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Asian
|
27 Participants
n=527 Participants
|
29 Participants
n=527 Participants
|
22 Participants
n=1054 Participants
|
78 Participants
n=157 Participants
|
|
Region of Enrollment
Vietnam
|
27 participants
n=527 Participants
|
29 participants
n=527 Participants
|
22 participants
n=1054 Participants
|
78 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week-4, -8, -12, -24Population: Missing data due to participants missing assessment or enable to provide blood draw at assessment
Change in plasma sCD14 concentration over 24 weeks
Outcome measures
| Measure |
XR-Naltrexone
n=21 Participants
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.
|
Methadone
n=27 Participants
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.
|
Buprenorphine
n=26 Participants
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.
|
|---|---|---|---|
|
Change in sCD14
Week 24
|
2096.4 pg/ML
Standard Deviation 287.9
|
1930.5 pg/ML
Standard Deviation 361.7
|
1946.2 pg/ML
Standard Deviation 415.1
|
|
Change in sCD14
Week 8
|
1601.2 pg/ML
Standard Deviation 219.6
|
1847.7 pg/ML
Standard Deviation 337.5
|
1848.6 pg/ML
Standard Deviation 352.4
|
|
Change in sCD14
Week 12
|
1565.9 pg/ML
Standard Deviation 237.4
|
1915.1 pg/ML
Standard Deviation 654.5
|
1833.4 pg/ML
Standard Deviation 280.4
|
|
Change in sCD14
Baseline
|
1746.4 pg/ML
Standard Deviation 307.7
|
1903.2 pg/ML
Standard Deviation 290.2
|
1907.8 pg/ML
Standard Deviation 377.2
|
|
Change in sCD14
Week 4
|
1675.3 pg/ML
Standard Deviation 408.5
|
1816.1 pg/ML
Standard Deviation 377.8
|
1897.5 pg/ML
Standard Deviation 310.7
|
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in CD38 concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in HLA-DR concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in PD1 expression in C8+ T cells over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in CD169 expression in monocytes over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in plasma sCD163 concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, week -12, -24Population: 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.
Change in type-I IFN signature over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in plasma hr-CRP concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in plasma d-dimer concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in plasma sTNFR-1 concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in plasma IL-6 and IL-10 concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: 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.
Change in plasma TGF-beta concentration over 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week-24Population: 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.
Change in plasma LPB concentration at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week-24Population: 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.
Change in plasma LPS concentration at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week-24Population: 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.
Change in plasma endo-CAB concentration at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week-24Population: 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.
Change in plasma I-FABP concentration at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week-24Population: 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.
Change in plasma Zonulin-1 concentration at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week-24Population: 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.
Change in s16rDNA concentration at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week-24Population: 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.
Change in bacterial butyryl-coA-coA concentration at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week-24Number of participants who were receiving treatment ar Week 4, 8, 12, 16, 20 and 24
Outcome measures
| Measure |
XR-Naltrexone
n=22 Participants
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.
|
Methadone
n=29 Participants
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.
|
Buprenorphine
n=27 Participants
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.
|
|---|---|---|---|
|
Retention in Care
Week 4
|
19 participants
|
27 participants
|
20 participants
|
|
Retention in Care
Week 8
|
17 participants
|
27 participants
|
18 participants
|
|
Retention in Care
Week 12
|
13 participants
|
26 participants
|
15 participants
|
|
Retention in Care
Week 16
|
11 participants
|
25 participants
|
12 participants
|
|
Retention in Care
Week 20
|
10 participants
|
25 participants
|
11 participants
|
|
Retention in Care
Week 24
|
10 participants
|
24 participants
|
11 participants
|
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: Missing data as participants missed some assessment points or unable to collect blood at the time of the assessment
Change in CD4 counts over 24 weeks
Outcome measures
| Measure |
XR-Naltrexone
n=22 Participants
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.
|
Methadone
n=28 Participants
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.
|
Buprenorphine
n=27 Participants
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.
|
|---|---|---|---|
|
HIV-related Outcomes: Change in CD4 Counts
Baseline
|
276 cells/µL
Standard Deviation 192.8
|
395.9 cells/µL
Standard Deviation 223.3
|
388.7 cells/µL
Standard Deviation 282.5
|
|
HIV-related Outcomes: Change in CD4 Counts
Week 4
|
429.4 cells/µL
Standard Deviation 343.9
|
389.8 cells/µL
Standard Deviation 164.3
|
397.5 cells/µL
Standard Deviation 290.6
|
|
HIV-related Outcomes: Change in CD4 Counts
Week 8
|
422.1 cells/µL
Standard Deviation 315.5
|
434.5 cells/µL
Standard Deviation 220.2
|
421.8 cells/µL
Standard Deviation 268.6
|
|
HIV-related Outcomes: Change in CD4 Counts
Week 12
|
404.3 cells/µL
Standard Deviation 257.5
|
410.6 cells/µL
Standard Deviation 201.2
|
454.3 cells/µL
Standard Deviation 267.1
|
|
HIV-related Outcomes: Change in CD4 Counts
Week 24
|
429.4 cells/µL
Standard Deviation 343.9
|
389.8 cells/µL
Standard Deviation 164.3
|
397.5 cells/µL
Standard Deviation 290.6
|
SECONDARY outcome
Timeframe: baseline, Week-4, -8, -12, -24Population: Missing data due to participants dropping off the study
Number of participants who get a ART medication at Baseline, Week 4, 8, 12, 24
Outcome measures
| Measure |
XR-Naltrexone
n=22 Participants
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.
|
Methadone
n=29 Participants
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.
|
Buprenorphine
n=27 Participants
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.
|
|---|---|---|---|
|
HIV-related Outcomes: cART Adherence
Baseline
|
22 Participants
|
29 Participants
|
27 Participants
|
|
HIV-related Outcomes: cART Adherence
Week 4
|
19 Participants
|
27 Participants
|
20 Participants
|
|
HIV-related Outcomes: cART Adherence
Week 8
|
17 Participants
|
27 Participants
|
18 Participants
|
|
HIV-related Outcomes: cART Adherence
Week 12
|
15 Participants
|
26 Participants
|
17 Participants
|
|
HIV-related Outcomes: cART Adherence
Week 24
|
10 Participants
|
24 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: baseline, Week-12, -24Population: Missing values due to participants missing the assessment or unable to collect blood at the time of assessment
HIV viral load at Baseline, Week-12, and Week-24
Outcome measures
| Measure |
XR-Naltrexone
n=22 Participants
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.
|
Methadone
n=29 Participants
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.
|
Buprenorphine
n=27 Participants
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.
|
|---|---|---|---|
|
HIV-related Clinical Outcomes: Viral Load
Baseline
|
124856.5 copies/µL
Standard Deviation 390131.1
|
67763.7 copies/µL
Standard Deviation 142533.9
|
6001.8 copies/µL
Standard Deviation 13601.9
|
|
HIV-related Clinical Outcomes: Viral Load
Week 12
|
12212.9 copies/µL
Standard Deviation 37198.5
|
2871.7 copies/µL
Standard Deviation 11177.6
|
1066.1 copies/µL
Standard Deviation 3147.2
|
|
HIV-related Clinical Outcomes: Viral Load
Week 24
|
114.1 copies/µL
Standard Deviation 212.1
|
38163.8 copies/µL
Standard Deviation 178734.7
|
260 copies/µL
Standard Deviation 724.1
|
SECONDARY outcome
Timeframe: Week 24Population: Drop out of participants
Comparison of number of participants who completed the treatment in each group
Outcome measures
| Measure |
XR-Naltrexone
n=22 Participants
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.
|
Methadone
n=29 Participants
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.
|
Buprenorphine
n=27 Participants
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.
|
|---|---|---|---|
|
Addiction Clinical Outcomes: Medication for Opioid Use Disorder (MOUD)
|
10 Participants
|
24 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week-4, -8, -12, -16, -20, -24Population: Percentage of opioid user among participants who have completed the time-point assessment
Number of participants with opioid use at Baseline, Week-4, 8, 12, 16, 20, and 24
Outcome measures
| Measure |
XR-Naltrexone
n=22 Participants
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.
|
Methadone
n=29 Participants
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.
|
Buprenorphine
n=27 Participants
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.
|
|---|---|---|---|
|
Addiction Clinical Outcomes: Change in Drug Use
Nb of opioid users at Week 24
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Addiction Clinical Outcomes: Change in Drug Use
Nb of opioid users at baseline
|
22 Participants
|
29 Participants
|
27 Participants
|
|
Addiction Clinical Outcomes: Change in Drug Use
Nb of opioid users at Week 4
|
2 Participants
|
22 Participants
|
19 Participants
|
|
Addiction Clinical Outcomes: Change in Drug Use
Nb of opioid users at Week 8
|
3 Participants
|
16 Participants
|
10 Participants
|
|
Addiction Clinical Outcomes: Change in Drug Use
Nb of opioid users at Week 12
|
1 Participants
|
13 Participants
|
9 Participants
|
|
Addiction Clinical Outcomes: Change in Drug Use
Nb of opioid users at Week 16
|
0 Participants
|
8 Participants
|
4 Participants
|
|
Addiction Clinical Outcomes: Change in Drug Use
Nb of opioid users at Week 20
|
1 Participants
|
5 Participants
|
4 Participants
|
Adverse Events
Methadone
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Buprenorphine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
XR-Naltrexone
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methadone
n=29 participants at risk
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.
|
Buprenorphine
n=27 participants at risk
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.
|
XR-Naltrexone
n=22 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/29 • 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.
|
0.00%
0/27 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
|
General disorders
Death
|
0.00%
0/29 • 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.
|
3.7%
1/27 • Number of events 1 • 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.
|
0.00%
0/22 • 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.
|
|
Surgical and medical procedures
Hip surgery
|
3.4%
1/29 • Number of events 1 • 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.
|
0.00%
0/27 • 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.
|
0.00%
0/22 • 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.
|
Other adverse events
| Measure |
Methadone
n=29 participants at risk
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.
|
Buprenorphine
n=27 participants at risk
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.
|
XR-Naltrexone
n=22 participants at risk
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.
|
|---|---|---|---|
|
General disorders
insomnia
|
0.00%
0/29 • 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.
|
0.00%
0/27 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/29 • 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.
|
0.00%
0/27 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Elevated AST/ALT
|
3.4%
1/29 • Number of events 1 • 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.
|
0.00%
0/27 • 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.
|
13.6%
3/22 • Number of events 3 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/29 • 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.
|
0.00%
0/27 • 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.
|
4.5%
1/22 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place