HIVPhase 4BRAVONCT01936857
Buprenorphine to Improve HIV Care Engagement and Outcomes
A Phase 4 study testing Buprenorphine/naloxone and Methadone Maintenance Therapy in people with HIV and Substance Related Disorders, run by Oregon Health and Science University at 6 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Substance Related Disorders
- What is being tested?
- Buprenorphine/naloxone and Methadone Maintenance Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 6 sitesVietnam
- Study dates
- Jul 2015to Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Vietnam6 sites
Bac Giang PAC OPC
Bắc Giang
Dong Da OPC
Hanoi
Hoang Mai HIV Clinic
Hanoi
Long Bien
Hanoi
Tu Liem
Hanoi
Thanh Hoa PAC OPC
Thanh Hóa
About this study
Official title: Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)
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.
- Conditions
- HIV, Substance Related Disorders
- Being tested
- Buprenorphine/naloxone, Methadone Maintenance Therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/naloxoneDrug
Also called Suboxone
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 TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine/naloxone | Experimental | Office based treatment of opioid dependence with buprenorphine/naloxone Receives: Drug: Buprenorphine/naloxone |
| Methadone Maintenance Therapy | Active comparator | Referral to methadone maintenance therapy for treatment of opioid dependence. Receives: Drug: Methadone Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With HIV Viral Suppression
HIV-1 RNA < 200 copies/mL
Measured: 12 months
Participants With Heroin Use (Urine Drug Screen)
Measured: 12 months
Participants With Heroin Use (Self-report)
Measured: 12 months
Secondary outcomes (2)
Number of Participants in Receipt of Antiretroviral Therapy (ART)
Initiation of and retention on treatment with antiretroviral medications.
Measured: 12 months
Number of Participants in Retention in HIV Care
HIV clinic visit in past 3 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startJul 2015
- Primary completionMar 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University, Hennepin Healthcare Research Institute
- Responsible party
- Principal investigator, P. Todd Korthuis, MD, Oregon Health and Science University
- Investigators
- Philip T Korthuis, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936857
- Sponsor's protocol ID
- 1R01DA037441_VNE
- Other IDs
- 1R01DA037441
- Acronym
- BRAVO
- Status last verified
- Apr 2022
- First submitted
- 3 Sep 2013
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Publications
Edsall A, Hoffman KA, Thuy DT, Mai PP, Hang NT, Khuyen TT, Trang NT, Kunkel LE, Giang LM, Korthuis PT. Use of methamphetamine and alcohol among people with opioid use disorder and HIV in Vietnam: a qualitative study. BMC Public Health. 2021 Sep 22;21(1):1718. doi: 10.1186/s12889-021-11783-9.
PubMed 34548042Korthuis PT, King C, Cook RR, Khuyen TT, Kunkel LE, Bart G, Nguyen T, Thuy DT, Bielavitz S, Nguyen DB, Tam NTM, Giang LM. HIV clinic-based buprenorphine plus naloxone versus referral for methadone maintenance therapy for treatment of opioid use disorder in HIV clinics in Vietnam (BRAVO): an open-label, randomised, non-inferiority trial. Lancet HIV. 2021 Feb;8(2):e67-e76. doi: 10.1016/S2352-3018(20)30302-7.
PubMed 33539760
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)
- ClinicalTrials.gov ID
- NCT01936857
- Acronym / sponsor ID
- BRAVO / 1R01DA037441_VNE
- Conditions
- HIV, Substance Related Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Hanoi Medical University, Hennepin Healthcare Research Institute
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Posted 24 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine/naloxone | Experimental | Drug: Buprenorphine/naloxoneOffice based treatment of opioid dependence with buprenorphine/naloxone |
| Methadone Maintenance Therapy | Active comparator | Drug: Methadone Maintenance TherapyReferral to methadone maintenance therapy for treatment of opioid dependence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine/naloxoneAlso: SuboxoneBuprenorphine/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. | Drug | Buprenorphine/naloxone |
| Methadone Maintenance TherapySubjects 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. | Drug | Methadone Maintenance Therapy |
Primary outcome
Number of Participants With HIV Viral Suppression
Time frame: 12 months
HIV-1 RNA < 200 copies/mL
Participants With Heroin Use (Urine Drug Screen)
Time frame: 12 months
Participants With Heroin Use (Self-report)
Time frame: 12 months
2 secondary outcomes
Number of Participants in Receipt of Antiretroviral Therapy (ART)
Time frame: 12 months
Number of Participants in Retention in HIV Care
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34548042Edsall A, Hoffman KA, Thuy DT, Mai PP, Hang NT, Khuyen TT, Trang NT, Kunkel LE, Giang LM, Korthuis PT. Use of methamphetamine and alcohol among people with opioid use disorder and HIV in Vietnam: a qualitative study. BMC Public Health. 2021 Sep 22;21(1):1718. doi: 10.1186/s12889-021-11783-9.
- Derived from this study: PubMed 33539760Korthuis PT, King C, Cook RR, Khuyen TT, Kunkel LE, Bart G, Nguyen T, Thuy DT, Bielavitz S, Nguyen DB, Tam NTM, Giang LM. HIV clinic-based buprenorphine plus naloxone versus referral for methadone maintenance therapy for treatment of opioid use disorder in HIV clinics in Vietnam (BRAVO): an open-label, randomised, non-inferiority trial. Lancet HIV. 2021 Feb;8(2):e67-e76. doi: 10.1016/S2352-3018(20)30302-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip T Korthuis, MD, MPH principal investigator
Oregon Health and Science University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine/naloxone and Methadone Maintenance Therapy in people with HIV and Substance Related Disorders, run by Oregon Health and Science University at 6 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With HIV Viral Suppression (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01936857, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.