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

NCT ID: NCT00857350

Last Updated: 2013-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Positive Opioid Dependence Opioid Agonist Treatment HIV Infections

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV+, opiod dependent

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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David Fiellin

Associate Professor of Medicine, Investigative Medicine and Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Fiellin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Jeanette Tetrault, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23388678 (View on PubMed)

Other Identifiers

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0709003082

Identifier Type: -

Identifier Source: org_study_id

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