Trial Outcomes & Findings for Buprenorphine to Improve HIV Care Engagement and Outcomes (NCT NCT01936857)
NCT ID: NCT01936857
Last Updated: 2022-05-17
Results Overview
HIV-1 RNA \< 200 copies/mL
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
281 participants
Primary outcome timeframe
12 months
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
Buprenorphine/Naloxone
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
140
|
|
Overall Study
COMPLETED
|
107
|
115
|
|
Overall Study
NOT COMPLETED
|
34
|
25
|
Reasons for withdrawal
| Measure |
Buprenorphine/Naloxone
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Overall Study
Sent to prison or 06 center
|
11
|
12
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
|
Overall Study
Death
|
7
|
3
|
|
Overall Study
Moved
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Side effect of medication
|
1
|
0
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
Buprenorphine to Improve HIV Care Engagement and Outcomes
Baseline characteristics by cohort
| Measure |
Buprenorphine/Naloxone
n=141 Participants
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=140 Participants
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Kinh
|
139 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Vietnam
|
141 participants
n=5 Participants
|
140 participants
n=7 Participants
|
281 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Follow up viral suppression was not available for 50 buprenorphine group participants, and 33 of methadone group participants.
HIV-1 RNA \< 200 copies/mL
Outcome measures
| Measure |
Buprenorphine/Naloxone
n=141 Participants
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=140 Participants
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Number of Participants With HIV Viral Suppression
Viral suppression at baseline
|
97 Participants
|
92 Participants
|
|
Number of Participants With HIV Viral Suppression
Viral suppression at 12 months
|
74 Participants
|
99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Buprenorphine/Naloxone
n=98 Participants
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=110 Participants
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Participants With Heroin Use (Urine Drug Screen)
|
66 Participants
|
72 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Buprenorphine/Naloxone
n=107 Participants
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=115 Participants
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Participants With Heroin Use (Self-report)
|
64 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: 12 monthsInitiation of and retention on treatment with antiretroviral medications.
Outcome measures
| Measure |
Buprenorphine/Naloxone
n=128 Participants
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=131 Participants
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Number of Participants in Receipt of Antiretroviral Therapy (ART)
|
108 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 12 monthsHIV clinic visit in past 3 months
Outcome measures
| Measure |
Buprenorphine/Naloxone
n=141 Participants
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=140 Participants
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Number of Participants in Retention in HIV Care
|
111 Participants
|
118 Participants
|
Adverse Events
Buprenorphine/Naloxone
Serious events: 10 serious events
Other events: 23 other events
Deaths: 7 deaths
Methadone Maintenance Therapy
Serious events: 4 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Buprenorphine/Naloxone
n=141 participants at risk
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=140 participants at risk
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accident, trauma, or external factor
|
4.3%
6/141 • Number of events 7 • 4 years
|
0.71%
1/140 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
Renal and urinary disorders
Nephrogenic
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
Immune system disorders
AIDS-related
|
2.1%
3/141 • Number of events 3 • 4 years
|
1.4%
2/140 • Number of events 2 • 4 years
|
|
General disorders
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.71%
1/140 • Number of events 1 • 4 years
|
|
General disorders
Malaise
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
Psychiatric disorders
Psychiatric
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
Psychiatric disorders
Suicide attempt
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
Other adverse events
| Measure |
Buprenorphine/Naloxone
n=141 participants at risk
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
|
Methadone Maintenance Therapy
n=140 participants at risk
Referral to methadone maintenance therapy for treatment of opioid dependence.
Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Unintentional injury
|
8.5%
12/141 • Number of events 12 • 4 years
|
1.4%
2/140 • Number of events 2 • 4 years
|
|
General disorders
Abnormal lab result
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
Nervous system disorders
Neuropathy
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.71%
1/140 • Number of events 1 • 4 years
|
|
Infections and infestations
Suspected infection
|
3.5%
5/141 • Number of events 5 • 4 years
|
0.00%
0/140 • 4 years
|
|
Vascular disorders
Vascular
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
Cardiac disorders
Cardiac
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.8%
4/141 • Number of events 4 • 4 years
|
0.00%
0/140 • 4 years
|
|
General disorders
Headache
|
1.4%
2/141 • Number of events 2 • 4 years
|
0.00%
0/140 • 4 years
|
|
Immune system disorders
Allergic reaction (non-study medication)
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
|
General disorders
Malaise
|
0.71%
1/141 • Number of events 1 • 4 years
|
0.00%
0/140 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place