Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Intravenous Drug Usage Clinical Trial

Official title:

Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831284
• Other study ID #: MMA-0774
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: November 4, 2014
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 anti-neoplastics (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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intravenous Drug Usage

Intervention

Procedure:
• Sigmoidoscopy with biopsy
Sigmoidoscopy with biopsy

Locations

Country	Name	City	State
United States	The Rockfeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the behavioral and immunological correlates of increased immune activation in active and former injection drug users (IDUs) in blood and tissue.	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.	3 months	No
Secondary	Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach.	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.	3 months	No