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Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)

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ClinicalTrials.gov Identifier: NCT01936857
Recruitment Status : Recruiting
First Posted : September 6, 2013
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):

September 3, 2013
September 6, 2013
June 5, 2017
July 2015
April 2018   (Final data collection date for primary outcome measure)
HIV Viral Suppression [ Time Frame: 12 months ]
HIV-1 RNA < 200 copies/mL
Same as current
Complete list of historical versions of study NCT01936857 on ClinicalTrials.gov Archive Site
  • Receipt of Antiretroviral Therapy (ART) [ Time Frame: 12 months ]
    Initiation of and retention on treatment with antiretroviral medications.
  • Retention in HIV care [ Time Frame: 12 months ]
    Attendance at scheduled HIV clinic visits.
  • Heroin use [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV
  • Substance Related Disorders
  • 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
  • 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.
  • Experimental: Buprenorphine/naloxone
    Office based treatment of opioid dependence with buprenorphine/naloxone
    Intervention: Drug: Buprenorphine/naloxone
  • Active Comparator: Methadone Maintenance Therapy
    Referral to methadone maintenance therapy for treatment of opioid dependence.
    Intervention: Drug: Methadone Maintenance Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2018
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Philip T Korthuis, MD, MPH 503-494-8044 korthuis@ohsu.edu
Contact: Giang M Le, MD 84-0913281842 leminhgiang@hmu.edu.vn
1R01DA037441 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
P. Todd Korthuis, Oregon Health and Science University
Oregon Health and Science University
  • Hanoi Medical University
  • Minneapolis Medical Research Foundation
Principal Investigator: Philip T Korthuis, MD, MPH Oregon Health and Science University
Oregon Health and Science University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP