We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857350
First Posted: March 6, 2009
Last Update Posted: July 22, 2013
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.
Information provided by (Responsible Party):
David Fiellin, Yale University
  Purpose

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
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 David Fiellin, Yale University:

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

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

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)
Groups/Cohorts
HIV+, opiod dependent

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV+, opioid dependent
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00857350


Locations
United States, Connecticut
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
  More Information

Publications:
Responsible Party: David Fiellin, Associate Professor of Medicine, Investigative Medicine and Public Health, Yale University
ClinicalTrials.gov Identifier: NCT00857350     History of Changes
Other Study ID Numbers: 0709003082
First Submitted: March 4, 2009
First Posted: March 6, 2009
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by David Fiellin, Yale University:
HIV
resistance
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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents