Clinical trial NCT01831284: Correlates and Consequences of Increased Immune Activation in Injection Drug Users
Official title: Correlates and Consequences of Increased Immune Activation in Injection Drug Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intravenous Drug Usage
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Examine the behavioral and immunological correlates of increased immune activation in active and former injection drug users (IDUs) in blood and tissue.
timeFrame: 3 months
Secondary outcomes:
measure: Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach.
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rockfeller University
state: New York
Study officials:
affiliation: Aaron Diamond AIDS Research Center
name: Martin Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.