Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Completed

• Conditions: Intravenous Drug Usage
• Interventions: Procedure: Sigmoidoscopy with biopsy

• Registration Number: NCT01831284
• Lead Sponsor: Rockefeller University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-15
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Former heroin injection drug users	Sigmoidoscopy with biopsy	Sigmoidoscopy with biopsy, in former injectors of heroin with or without other agents
healthy controls	Sigmoidoscopy with biopsy	Sigmoidoscopy with biopsy, in non-injecting controls-
heroin injecting drug users	Sigmoidoscopy with biopsy	Sigmoidoscopy with biopsy, in medically stable active injecting drug users

Primary Outcome Measures

Name	Time	Method
Examine the behavioral and immunological correlates of increased immune activation in active and former injection drug users (IDUs) in blood and tissue.	3 months	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

Name	Time	Method
Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach.	3 months	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.

Trial Locations

Locations (1)

The Rockfeller University; 🇺🇸 New York, New York, United States