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NCT00857350 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00857350
Other study ID # 0709003082
Secondary ID
Status Completed
Phase N/A
First received March 4, 2009
Last updated July 19, 2013
Start date June 2008
Est. completion date September 2012

Study information
Verified date July 2013
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2012
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Yale University Hospital New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.0b0 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HIV drug resistance Cross sectional No
Secondary Illicit drug use 6 months No
Secondary HIV transmission risk behaviors 1 year No
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