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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Fiellin, Yale University
ClinicalTrials.gov Identifier:
NCT00857350
First received: March 4, 2009
Last updated: July 19, 2013
Last verified: July 2013

March 4, 2009
July 19, 2013
June 2008
June 2010   (final data collection date for primary outcome measure)
HIV drug resistance [ Time Frame: Cross sectional ] [ Designated as safety issue: No ]
HAART adherence. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00857350 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Ongoing illicit drug use: 1+ month of opioid treatment and has 2+ urine toxicology analyses over the prior 6 months. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • HIV drug resistance: IAS-USA 2006 mutation table. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • HIV transmission risk behaviors: ARI forms (HIV transmission risk behaviors) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment

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.
Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

HIV+, opioid dependent

  • HIV Positive
  • Opioid Dependence
  • Opioid Agonist Treatment
  • HIV Infections
Not Provided
HIV+, opiod dependent
Tetrault JM, Kozal MJ, Chiarella J, Sullivan LE, Dinh AT, Fiellin DA. Association between risk behaviors and antiretroviral resistance in HIV-infected patients receiving opioid agonist treatment. J Addict Med. 2013 Mar-Apr;7(2):102-7. doi: 10.1097/ADM.0b013e31827f9bdf.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2012
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00857350
0709003082
No
David Fiellin, Yale University
Yale University
Not Provided
Principal Investigator: David Fiellin, MD Yale School of Medicine
Principal Investigator: Jeanette Tetrault, MD Yale University
Yale University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP