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Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01936857
Recruitment Status : Recruiting
First Posted : September 6, 2013
Last Update Posted : June 5, 2017
Hanoi Medical University
Minneapolis Medical Research Foundation
Information provided by (Responsible Party):
P. Todd Korthuis, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
HIV Substance Related Disorders Drug: Buprenorphine/naloxone Drug: Methadone Maintenance Therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)
Actual Study Start Date : July 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: Buprenorphine/naloxone
Office based treatment of opioid dependence with buprenorphine/naloxone
Drug: 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.
Other Name: Suboxone
Active Comparator: Methadone Maintenance Therapy
Referral to methadone maintenance therapy for treatment of opioid dependence.
Drug: 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.

Primary Outcome Measures :
  1. HIV Viral Suppression [ Time Frame: 12 months ]
    HIV-1 RNA < 200 copies/mL

Secondary Outcome Measures :
  1. Receipt of Antiretroviral Therapy (ART) [ Time Frame: 12 months ]
    Initiation of and retention on treatment with antiretroviral medications.

  2. Retention in HIV care [ Time Frame: 12 months ]
    Attendance at scheduled HIV clinic visits.

  3. Heroin use [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV positive
  • Current moderate or severe 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
  • AST & 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01936857

Contact: Philip T Korthuis, MD, MPH 503-494-8044
Contact: Giang M Le, MD 84-0913281842

Bac Giang PAC OPC Active, not recruiting
Bac Giang, Vietnam
Dong Da OPC Recruiting
Hanoi, Vietnam
Hoang Mai HIV Clinic Recruiting
Hanoi, Vietnam
Long Bien Recruiting
Hanoi, Vietnam
Tu Liem Recruiting
Hanoi, Vietnam
Thanh Hoa PAC OPC Active, not recruiting
Thanh Hoa, Vietnam
Sponsors and Collaborators
Oregon Health and Science University
Hanoi Medical University
Minneapolis Medical Research Foundation
Principal Investigator: Philip T Korthuis, MD, MPH Oregon Health and Science University

Responsible Party: P. Todd Korthuis, Associate Professor of Medicine, Oregon Health and Science University Identifier: NCT01936857     History of Changes
Other Study ID Numbers: 1R01DA037441_VNE
1R01DA037441 ( U.S. NIH Grant/Contract )
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents