Buprenorphine to Improve HIV Care Engagement and Outcomes

HIV Clinical Trial

— BRAVO  

Official title:

Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936857
• Other study ID #: 1R01DA037441_VNE
• Secondary ID: 1R01DA037441
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: April 2019

Study information

• Verified date: April 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV positive

• Current moderate or severe Diagnostic and Statistical Manual (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

• aspartate aminotransferase (AST) & alanine aminotransferase (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

Related Conditions & MeSH terms

• HIV
• Substance Related Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Vietnam	Bac Giang PAC OPC	Bac Giang
Vietnam	Dong Da OPC	Hanoi
Vietnam	Hoang Mai HIV Clinic	Hanoi
Vietnam	Long Bien	Hanoi
Vietnam	Tu Liem	Hanoi
Vietnam	Thanh Hoa PAC OPC	Thanh Hoa

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Hanoi Medical University, Hennepin Healthcare Research Institute

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With HIV Viral Suppression	HIV-1 RNA < 200 copies/mL	12 months
Primary	Participants With Heroin Use (Urine Drug Screen)		12 months
Primary	Participants With Heroin Use (Self-report)		12 months
Secondary	Number of Participants in Receipt of Antiretroviral Therapy (ART)	Initiation of and retention on treatment with antiretroviral medications.	12 months
Secondary	Number of Participants in Retention in HIV Care	HIV clinic visit in past 3 months	12 months