HIV PositiveNCT00857350
The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
An observational study of HIV Positive and Opioid Dependence, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HIV Positive, Opioid Dependence, Opioid Agonist Treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV+, opioid dependent
Who may be able to join
- HIV+
- Opioid dependent
- Receiving methadone or buprenorphine for at least one month
Who cannot join
- age < 18 years
- current dementia;
- inability to read or understand English
- inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Hospital
New Haven, Connecticut, 06511
About this study
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:
- Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.
- Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to have HIV drug resistance.
- Keywords
- HIV, resistance, opioid dependence
- Medical subject headings
- HIV Seropositivity, Opioid-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV+, opiod dependent | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV drug resistance
Measured: Cross sectional
Secondary outcomes (2)
Illicit drug use
Measured: 6 months
HIV transmission risk behaviors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Fiellin, Yale University
- Investigators
- David Fiellin, MD, Principal investigator, Yale UniversityJeanette Tetrault, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857350
- Sponsor's protocol ID
- 0709003082
- Status last verified
- Jul 2013
- First submitted
- 4 Mar 2009
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23388678
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
- ClinicalTrials.gov ID
- NCT00857350
- Acronym / sponsor ID
- 0709003082
- Keywords
- HIV, resistance, opioid dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.
- Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to have HIV drug resistance.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV+, opiod dependent | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV+, opioid dependent
Key inclusion criteria (3 listed)
- HIV+
- Opioid dependent
- Receiving methadone or buprenorphine for at least one month
Key exclusion criteria (4 listed)
- age < 18 years
- current dementia;
- inability to read or understand English
- inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIV drug resistance
Time frame: Cross sectional
2 secondary outcomes
Illicit drug use
Time frame: 6 months
HIV transmission risk behaviors
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Results publication: PubMed 23388678Tetrault 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Fiellin, MD principal investigator
Yale University
Jeanette Tetrault, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Positive and Opioid Dependence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV drug resistance (time frame: Cross sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00857350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013.