Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-25 @ 8:28 AM
Study NCT ID:
NCT00348868
Status:
COMPLETED
Last Update Posted:
2008-03-18
First Post:
2006-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buprenorphine HIV Care Integration Project
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
Miami Buprenorphine HIV Care Integration Project
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
Detailed Description:
DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.
SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.
POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.
STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)
INTERVENTON At entry subjects will be randomized to one of the following:
ARM A: Standard drug addiction counseling + buprenorphine / naloxone
ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone
The three primary outcomes are:
1. Cessation of illicit opioid use
2. Reduction in high risk behavior
3. Improved HIV therapy adherence
DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.
SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.
POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.
STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)
INTERVENTON At entry subjects will be randomized to one of the following:
ARM A: Standard drug addiction counseling + buprenorphine / naloxone
ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone
The three primary outcomes are:
1. Cessation of illicit opioid use
2. Reduction in high risk behavior
3. Improved HIV therapy adherence
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: