NCT00857350

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. 1.Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.
  2. 2.Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to have HIV drug resistance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

March 4, 2009

Last Update Submit

July 19, 2013

Conditions

HIV PositiveOpioid DependenceOpioid Agonist TreatmentHIV Infections

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+
  • 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.

Sponsors & Collaborators

Study Sites (1)

Yale University Hospital

New Haven, Connecticut, 06511, United States

Location

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 SyndromesImmune System DiseasesNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • David Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Jeanette Tetrault, MD

    Yale University

    PRINCIPAL INVESTIGATOR

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 1, 2008

Primary Completion

June 1, 2010

Study Completion

September 1, 2012

Last Updated

July 22, 2013

Record last verified: 2013-07

Locations

US(1)