NCT00857350

Completed

The Prevalence of HIV Drug Resistance and Transmission Risk ...

Yale University Source

Other study identifiers

Sponsor study identifier

0709003082

Study Type

observational

Actual enrollment (reported)

60

Locations

1 country

Sites

1

Timeline

Study Start

June 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2010

Actual (reported)

Study Completion

September 2012

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 60 participants
Study completion date: September 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 4, 2009
Actual (reported)
First Posted
March 6, 2009
Actual (reported)
Primary Completion
June 2010
Actual (reported)
Study Completion
September 2012
Actual (reported)

Last Updated: July 22, 2013
Status Verified: July 2013
Last Update Submitted: July 19, 2013

Conditions

HIV Infections HIV Positive Opioid Agonist Treatment Opioid Dependence

Keywords

HIVresistanceopioid dependence

Outcome Measures

Primary Outcomes (1)

HIV drug resistance
Cross sectional

Secondary Outcomes (2)

Illicit drug use
6 months
HIV transmission risk behaviors
1 year

Study Arms (1)

HIV+, opiod dependent

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

HIV+, opioid dependent

You may qualify if:

HIV+

Sponsors & Collaborators

Yale University
Otherlead

Study Sites (1)

Yale University Hospital

New Haven, Connecticut, 06511, United States

Related 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.0b013e31827f9bdf.
PMID: 23388678RESULT

MeSH Terms

Conditions

HIV SeropositivityOpioid-Related DisordersHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency Syndromes

Study Officials

David Fiellin, MD
Yale University
PRINCIPAL INVESTIGATOR
Jeanette Tetrault, MD
Yale University
PRINCIPAL INVESTIGATOR

Enrollment

60 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: ECOLOGIC OR COMMUNITY
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor of Medicine, Investigative Medicine and Public Health

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

June 2008

Date type not reported

This date has not been verified as actual or estimated.

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Not ApplicableCompleted

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Phase 3Terminated

NCT00555425

Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Phase 4Completed

NCT00836290

Positive Lifestyles Using Safety

Not ApplicableCompleted

NCT00913770

Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department

Not ApplicableCompleted

Opioid dependent

Receiving methadone or buprenorphine for at least one month

You may not qualify if:

age \< 18 years
current dementia;
inability to read or understand English
inability to provide written informed consent

Contact the study team to confirm eligibility.

Immune System Diseases

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Primary Completion

June 2010

Actual (reported)

Study Completion

September 2012

Actual (reported)

Last Updated

July 22, 2013

Record last verified: 2013-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00857350
Data provider: ClinicalTrials.gov
Source updated: 2013-07-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:39 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

HIV+, opiod dependent

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations