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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
HIV Infections
Opioid-Related Disorders
Chemically-Induced Disorders
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 May 30, 2016