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The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT00857350
Collaborator
(none)
60
Enrollment
1
Location
51
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

HIV drug resistance presents a significant public heath problem. This proposal is designed to explore the association between ongoing illicit drug use and the prevalence of HIV drug resistance among HIV+ opioid dependent patients receiving opioid agonist treatment with the following hypotheses:

  1. Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.

  2. Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to have HIV drug resistance.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Sep 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    HIV+, opiod dependent

    Outcome Measures

    Primary Outcome Measures

    1. HIV drug resistance [Cross sectional]

    Secondary Outcome Measures

    1. Illicit drug use [6 months]

    2. HIV transmission risk behaviors [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • HIV+

    • Opioid dependent

    • Receiving methadone or buprenorphine for at least one month

    Exclusion Criteria:

    • age < 18 years

    • current dementia;

    • inability to read or understand English

    • inability to provide written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale University Hospital New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: David Fiellin, MD, Yale School of Medicine
    • Principal Investigator: Jeanette Tetrault, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Fiellin, Associate Professor of Medicine, Investigative Medicine and Public Health, Yale University
    ClinicalTrials.gov Identifier:
    NCT00857350
    Other Study ID Numbers:
    • 0709003082
    First Posted:
    Mar 6, 2009
    Last Update Posted:
    Jul 22, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by David Fiellin, Associate Professor of Medicine, Investigative Medicine and Public Health, Yale University
    HIV
    resistance
    opioid dependence
    Additional relevant MeSH terms:
    HIV Seropositivity
    Opioid-Related Disorders

    Study Results

    No Results Posted as of Jul 22, 2013