MedTrace Logo

Buprenorphine to Improve HIV Care Engagement and Outcomes

NCT01936857 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2022-05-17

Study results available
· View outcomes & findings →

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.

Conditions

  • HIV
  • Substance Related Disorders

Interventions

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.

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.

Sponsors & Collaborators

  • Hanoi Medical University

    collaborator OTHER

  • Hennepin Healthcare Research Institute

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Philip T Korthuis, MD, MPH · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-03-31
Completion
2019-04-30

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936857 on ClinicalTrials.gov