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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857350
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : July 22, 2013
Information provided by (Responsible Party):
David Fiellin, Yale University

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
HIV Positive Opioid Dependence Opioid Agonist Treatment HIV Infections

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 : June 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

HIV+, opiod dependent

Primary Outcome Measures :
  1. HIV drug resistance [ Time Frame: Cross sectional ]

Secondary Outcome Measures :
  1. Illicit drug use [ Time Frame: 6 months ]
  2. HIV transmission risk behaviors [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
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
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by David Fiellin, Yale University:
opioid dependence

Additional relevant MeSH terms:
HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents