Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Plain-language summary

This study examined increased immune system activation and its consequences in people who inject drugs, using sigmoidoscopy with biopsy for evaluation. It included people aged 18-55 who could provide informed consent and had no medical condition preventing the procedure. The study was carried out as a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Rockefeller University

Intervention

Sigmoidoscopy with biopsy

Start date

12/1/2012

Estimated completion

9/1/2014

Countries

United States

Related genes

Locations

• New York, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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