Phase 4
Completed N=281
Buprenorphine to Improve HIV Care Engagement and Outcomes
Source: ClinicalTrials.gov NCT01936857 ↗Enrolled (actual)
281
Serious AEs
5.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With HIV Viral Suppression — 97; 92; 74; 99 Participants
◆ Published Evidence
Established
22citations · ~4 / year
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.
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.
Linked Publications (2)
-
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.
-
Use of methamphetamine and alcohol among people with opioid use disorder and HIV in Vietnam: a qualitative study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With HIV Viral Suppression |
97; 92; 74; 99 | — |
| PRIMARY Participants With Heroin Use (Urine Drug Screen) |
66; 72 | — |
| PRIMARY Participants With Heroin Use (Self-report) |
64; 67 | — |
| SECONDARY Number of Participants in Receipt of Antiretroviral Therapy (ART) |
108; 116 | — |
| SECONDARY Number of Participants in Retention in HIV Care |
111; 118 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01936857) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.