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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00857350
First received: March 4, 2009
Last updated: May 4, 2011
Last verified: May 2011
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ]

Estimated Enrollment: 90
Study Start Date: June 2008
Estimated Study Completion Date: September 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV+, opiod dependent

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Fiellin, Yale School of Medicine
ClinicalTrials.gov Identifier: NCT00857350     History of Changes
Other Study ID Numbers: 0709003082
Study First Received: March 4, 2009
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
HIV
resistance
opioid dependence

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 19, 2013