Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Oregon Health and Science University
Sponsor:
Collaborators:
Hanoi Medical University
Minneapolis Medical Research Foundation
Information provided by (Responsible Party):
P. Todd Korthuis, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01936857
First received: September 3, 2013
Last updated: July 17, 2015
Last verified: July 2015
  Purpose

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 Intervention Phase
HIV
Substance Related Disorders
Drug: Buprenorphine/naloxone
Drug: Methadone Maintenance Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • HIV Viral Suppression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    HIV-1 RNA < 200 copies/mL


Secondary Outcome Measures:
  • Receipt of Antiretroviral Therapy (ART) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Initiation of and retention on treatment with antiretroviral medications.

  • Retention in HIV care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Attendance at scheduled HIV clinic visits.

  • Heroin use [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: July 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New to HIV care or registered but not on ART
  • No ART in past 3 months
  • Current moderate or severe DSM-V opioid dependence
  • Urine drug screen positive for opioids
  • Interested in receiving treatment for opioid dependence
  • Age at least 18 years old
  • Have a CD4 count eligible to receive ART
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936857

Contacts
Contact: Philip T Korthuis, MD, MPH 503-494-8044 korthuis@ohsu.edu
Contact: Giang M Le, MD 84-0913281842 leminhgiang@hmu.edu.vn

Locations
Vietnam
Bac Giang PAC OPC Recruiting
Bac Giang, Vietnam
Hanoi PAC OPC Not yet recruiting
Hanoi, Vietnam
Hoang Mai HIV Clinic Not yet recruiting
Hanoi, Vietnam
Thanh Hoa PAC OPC Recruiting
Thanh Hoa, Vietnam
Sponsors and Collaborators
Oregon Health and Science University
Hanoi Medical University
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: Philip T Korthuis, MD, MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: P. Todd Korthuis, Associate Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01936857     History of Changes
Other Study ID Numbers: 1R01DA037441_VNE
Study First Received: September 3, 2013
Last Updated: July 17, 2015
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board
Vietnam: Ministry of Health

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

ClinicalTrials.gov processed this record on August 02, 2015