Correlates and Consequences of Increased Immune Activation in Injection Drug Users

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT01831284
First received: February 28, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The goal of this study is to learn how injection drug use may affect the immune system.


Condition Intervention
Healthy Volunteers
Procedure: Sigmoidoscopy with biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Examine the behavioral and immunological correlates of increased immune activation in active and former injection drug users (IDUs) in blood and tissue. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Detailed assessments of blood and GI tissue including measurements of HCV viremia in 1) active HIV-1-uninfected IDUs (N=48) 2) a cohort of individuals entering or in drug treatment programs who have stopped injecting for approximately 1 and 3 months (N=48), the majority of whom we anticipate will be infected with HCV; and 3) non-injecting controls (N=48). In addition to obtaining blood and tissue, we will collect behavioral data including injection and other drug use and sexual behaviors.


Secondary Outcome Measures:
  • Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This study will isolate specific cell populations from the peripheral blood as well as the GALT that mediate innate and adaptive immune responses. We will perform transcriptional profiling with the goal of identifying gene expression patterns of a-priori defined biological pathways and functional categories that associate with phenotypes of interest. Finally to complement and clarify the results of our in vivo studies, we will examine the in vitro effects of adding morphine and methadone and withdrawing opiates on T cell subsets of interest using a systems biology approach.


Biospecimen Retention:   Samples Without DNA

Sigmoidoscopy with biopsy


Estimated Enrollment: 144
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
medically stable active injecting drug users
Medically stable active injecting drug users- injection of heroin with or without other agents at least 3 times a week (N=48);
Procedure: Sigmoidoscopy with biopsy
Sigmoidoscopy with biopsy
non-injecting controls
non-injecting controls- no lifetime use of injection drugs and no illicit non-injection opiate or cocaine for at least 3 years
Procedure: Sigmoidoscopy with biopsy
Sigmoidoscopy with biopsy
Former injectors of heroin with or without other agents
Former injectors of heroin with or without other agents will be recruited and followed longitudinally but if necessary cross-sectionally after approximately 1 month (N=48) and 3 months (N=48) from the time of last injection
Procedure: Sigmoidoscopy with biopsy
Sigmoidoscopy with biopsy

Detailed Description:

The goal of this study is to learn how injection drug use may affect the immune system. One way to measure this is by looking at the blood and the gut, or gastrointestinal tract at the same time. It is thought that activating the immune system by injection drug use may increase destruction of immune cells in the gut. To test this theory, the investigators are enrolling HIV-negative injection drug users, HIV-negative people who do not use drugs and HIV-negative former injection drug users.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Group 1: HIV-uninfected, active IDU defined as a minimum of 3 injections of heroin per week (N=48)

Group 2: Non-injecting controls defined as no lifetime use of injection drugs and no illicit non-injection opiate or cocaine for at least 3 years (N=48)

Group 3: Former injectors of heroin with or without other agents will be recruited and followed longitudinally but if necessary cross-sectionally after approximately 1 month (N=48) and 3 months (N=48) from the time of last injection.

All groups will be matched for age, sex, and race/ethnicity. Groups 1 and 3 will be matched for Hepatitis C status and HCV RNA levels. Group 1 subjects will be studied twice; at baseline and after 1-2 months to assess stability of findings. Group 2 will be studied one time, and Group 3 will be studied at 1 month and 3 months after ceasing injection behavior.

Criteria

Inclusion Criteria:

  • Ability to give informed consent
  • Between the ages of 18 and 55
  • Absence of medical conditions that would preclude flexible sigmoidoscopy
  • Absence of active opportunistic infection requiring active therapy including antibiotics or antineoplastics (note this does not include prophylactic antibiotic therapy)

Exclusion Criteria:

  • History of bleeding disorder
  • Platelet count below 70,000
  • INR>1.5 or PTT>2X control
  • Active use of anticoagulants or aspirin therapy that cannot be interrupted
  • Comorbid diagnosis of inflammatory bowel disease
  • Pregnancy, incarceration, mentally disabled individuals
  • HIV-1 infection
  • Currently on Hepatitis C treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831284

Locations
United States, New York
The Rockfeller University Recruiting
New York, New York, United States, 10065
Contact: Recruitment Office    212-782-2737      
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Martin Markowitz, MD ADARC
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01831284     History of Changes
Other Study ID Numbers: MMA-0774
Study First Received: February 28, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 02, 2014