HIV, Substance Related Disorders
Conditions
Brief summary
The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.
Interventions
DRUGBuprenorphine/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.
DRUGMethadone 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.
Sponsors
Hanoi Medical University
Hennepin Healthcare Research Institute
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV positive * Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder * Urine drug screen positive for opioids * Interested in receiving treatment for opioid dependence * Age at least 18 years old * Willing to practice an effective method of birth control, if female
Exclusion criteria
* Known hypersensitivity to buprenorphine or naloxone * aspartate aminotransferase (AST) & alanine aminotransferase (ALT) \> 5x upper limit * Currently pregnant or breastfeeding * Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician * Methadone maintenance treatment within 30 days of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HIV Viral Suppression | 12 months | HIV-1 RNA \< 200 copies/mL |
| Participants With Heroin Use (Urine Drug Screen) | 12 months | — |
| Participants With Heroin Use (Self-report) | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Receipt of Antiretroviral Therapy (ART) | 12 months | Initiation of and retention on treatment with antiretroviral medications. |
| Number of Participants in Retention in HIV Care | 12 months | HIV clinic visit in past 3 months |
Countries
Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 141 |
| 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. | 140 |
| Total | 281 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 3 |
| Overall Study | Lost to Follow-up | 10 | 7 |
| Overall Study | Moved | 2 | 1 |
| Overall Study | Other | 2 | 2 |
| Overall Study | Sent to prison or 06 center | 11 | 12 |
| Overall Study | Side effect of medication | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Buprenorphine/Naloxone | Methadone Maintenance Therapy | Total |
|---|---|---|---|
| Age, Continuous | 38.0 years STANDARD_DEVIATION 5.8 | 38.6 years STANDARD_DEVIATION 6.4 | 38.3 years STANDARD_DEVIATION 6.1 |
| Race/Ethnicity, Customized Kinh | 139 Participants | 139 Participants | 278 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment Vietnam | 141 participants | 140 participants | 281 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 136 Participants | 136 Participants | 272 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 141 | 3 / 140 |
| other Total, other adverse events | 23 / 141 | 3 / 140 |
| serious Total, serious adverse events | 10 / 141 | 4 / 140 |
Outcome results
Primary
Number of Participants With HIV Viral Suppression
HIV-1 RNA \< 200 copies/mL
Time frame: 12 months
Population: Follow up viral suppression was not available for 50 buprenorphine group participants, and 33 of methadone group participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Buprenorphine/Naloxone | Number of Participants With HIV Viral Suppression | Viral suppression at baseline | 97 Participants |
| Buprenorphine/Naloxone | Number of Participants With HIV Viral Suppression | Viral suppression at 12 months | 74 Participants |
| Methadone Maintenance Therapy | Number of Participants With HIV Viral Suppression | Viral suppression at baseline | 92 Participants |
| Methadone Maintenance Therapy | Number of Participants With HIV Viral Suppression | Viral suppression at 12 months | 99 Participants |
Primary
Participants With Heroin Use (Self-report)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine/Naloxone | Participants With Heroin Use (Self-report) | 64 Participants |
| Methadone Maintenance Therapy | Participants With Heroin Use (Self-report) | 67 Participants |
Primary
Participants With Heroin Use (Urine Drug Screen)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine/Naloxone | Participants With Heroin Use (Urine Drug Screen) | 66 Participants |
| Methadone Maintenance Therapy | Participants With Heroin Use (Urine Drug Screen) | 72 Participants |
Secondary
Number of Participants in Receipt of Antiretroviral Therapy (ART)
Initiation of and retention on treatment with antiretroviral medications.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine/Naloxone | Number of Participants in Receipt of Antiretroviral Therapy (ART) | 108 Participants |
| Methadone Maintenance Therapy | Number of Participants in Receipt of Antiretroviral Therapy (ART) | 116 Participants |
Secondary
Number of Participants in Retention in HIV Care
HIV clinic visit in past 3 months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buprenorphine/Naloxone | Number of Participants in Retention in HIV Care | 111 Participants |
| Methadone Maintenance Therapy | Number of Participants in Retention in HIV Care | 118 Participants |