Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)

Oregon Health & Science University (OHSU)

Status and phase

Completed

Phase 4

Conditions

HIV

Substance Related Disorders

Treatments

Drug: Buprenorphine/naloxone

Drug: Methadone Maintenance Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01936857

1R01DA037441_VNE

1R01DA037441 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

281 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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