Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Buprenorphine to Improve HIV Care Engagement and Outcomes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 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: April 24, 2014
Last verified: April 2014

September 3, 2013
April 24, 2014
May 2014
April 2018   (final data collection date for primary outcome measure)
HIV Viral Suppression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ 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 ]
Same as current
Not Provided
Not Provided
 
Buprenorphine to Improve HIV Care Engagement and Outcomes
Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Substance Related Disorders
  • Drug: Buprenorphine/naloxone
    Buprenorphine/naloxone induction begins with a 2mg 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. Subjects will return at least twice in the first week for re-evaluation and take-outs, then weekly for 4 weeks, then every 2 weeks for 4 weeks, then monthly, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg and maximum take-out period of 4 weeks, 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.
 
Not yet recruiting
450
April 2018
April 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • New to HIV care or registered but not on ART
  • No ART in past 3 months
  • Current DSM-IV opioid dependence
  • Interested in receiving treatment
  • Age 18-65
  • CD4 < 350 cells/mL
  • Willing to practice an effective method of birth control, if female

Exclusion Criteria:

  • Known hypersensitivity to buprenorphine or naloxone
  • AST & ALT > 5x upper limit
  • Pregnancy
  • 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
Both
18 Years to 65 Years
No
Contact: Philip T Korthuis, MD, MPH 503-494-8044 korthuis@ohsu.edu
Contact: Giang M Le, MD 84-0913281842 leminhgiang@hmu.edu.vn
Vietnam
 
NCT01936857
1R01DA037441_VNE
Yes
P. Todd Korthuis, Oregon Health and Science University
Oregon Health and Science University
  • Hanoi Medical University
  • Minneapolis Medical Research Foundation
Not Provided
Oregon Health and Science University
April 2014

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