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

This study has been completed.
Information provided by (Responsible Party):
David Fiellin, Yale University Identifier:
First received: March 4, 2009
Last updated: July 19, 2013
Last verified: July 2013

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.

HIV Positive
Opioid Dependence
Opioid Agonist Treatment
HIV Infections

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • HIV drug resistance [ Time Frame: Cross sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Illicit drug use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HIV transmission risk behaviors [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2008
Study Completion Date: September 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
HIV+, opiod dependent


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV+, opioid dependent


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
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Please refer to this study by its identifier: NCT00857350

United States, Connecticut
Yale University Hospital
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Principal Investigator: David Fiellin, MD Yale School of Medicine
Principal Investigator: Jeanette Tetrault, MD Yale University
  More Information

Responsible Party: David Fiellin, Associate Professor of Medicine, Investigative Medicine and Public Health, Yale University Identifier: NCT00857350     History of Changes
Other Study ID Numbers: 0709003082
Study First Received: March 4, 2009
Last Updated: July 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
opioid dependence

Additional relevant MeSH terms:
HIV Seropositivity
Opioid-Related Disorders
Chemically-Induced Disorders
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mental Disorders
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Substance-Related Disorders
Virus Diseases processed this record on October 13, 2015