Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intravenous Drug Usage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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heroin injecting drug users

Sigmoidoscopy with biopsy, in medically stable active injecting drug users

Sigmoidoscopy with biopsy

Intervention Type PROCEDURE

Sigmoidoscopy with biopsy

healthy controls

Sigmoidoscopy with biopsy, in non-injecting controls-

Sigmoidoscopy with biopsy

Intervention Type PROCEDURE

Sigmoidoscopy with biopsy

Former heroin injection drug users

Sigmoidoscopy with biopsy, in former injectors of heroin with or without other agents

Sigmoidoscopy with biopsy

Intervention Type PROCEDURE

Sigmoidoscopy with biopsy

Interventions

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Sigmoidoscopy with biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes