Correlates and Consequences of Increased Immune Activation in Injection Drug Users

NCT01831284 | Completed

• 1 other identifier: MMA-0774
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intravenous Drug Usage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach.

  3 months

Study Arms (3)

heroin injecting drug users

Sigmoidoscopy with biopsy, in medically stable active injecting drug users

Procedure: Sigmoidoscopy with biopsy

healthy controls

Sigmoidoscopy with biopsy, in non-injecting controls-

Procedure: Sigmoidoscopy with biopsy

Former heroin injection drug users

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

Procedure: Sigmoidoscopy with biopsy

Interventions

Sigmoidoscopy with biopsy PROCEDURE

Sigmoidoscopy with biopsy

Former heroin injection drug users; healthy controls; heroin injecting drug users

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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/without other agents will be recruited and followed 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, at 1-2 months to assess stability of findings. Group 2 will be studied once; Group 3 will be studied at 1 and 3 months after ceasing injections.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockfeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• Markowitz M, Deren S, Cleland C, La Mar M, Silva E, Batista P, St Bernard L, Gettie N, Rodriguez K, Evering TH, Lee H, Mehandru S. Chronic Hepatitis C Virus Infection and the Proinflammatory Effects of Injection Drug Use. J Infect Dis. 2016 Nov 1;214(9):1376-1382. doi: 10.1093/infdis/jiw373. Epub 2016 Aug 11.

  PMID: 27521361 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sigmoidoscopy with biopsy

MeSH Terms

Interventions

Sigmoidoscopy; Biopsy

Intervention Hierarchy (Ancestors)

Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Martin Markowitz, MD

  Aaron Diamond AIDS Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: April 15, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

US (1)