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Protocol Details

Biomarkers of Inflammation, Coagulation, and Endothelial Function in HIV-Infected Adults

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years

Referral Letter Required


Population Exclusion(s)



Immunologic Non-Responder;
Cardiovascular Disease;
Natural History

Recruitment Keyword(s)

HIV Positive;
HIV Negative;
Healthy Volunteer;


Pathologic Processes

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases

This study will collect information about markers of inflammation, blood clotting and blood vessel function in HIV-infected adults and healthy volunteers. Biomarkers are biological indicators that have been associated with disease. Certain markers of inflammation, blood clotting, and blood vessel function have been associated with risk of cardiovascular disease, stroke and death. One marker, called D-dimer, is a breakdown product of blood clots that has been associated with serious medical conditions, including deep vein thrombosis (formation of a blood clot in a vein deep in the body) and pulmonary embolism (blockage in the pulmonary artery that occurs when a blood clot from a vein breaks away, travels to the pulmonary artery and lodges there). High D-dimer levels have also been associated with cardiovascular disease and stroke risk. In a recent study of HIV-infected patients, higher D-dimer levels were strongly correlated with risk of death from any cause. The significance of changes in D-dimer and other biomarkers in HIV-infected adults is not well understood. This study will further explore D-dimer and other biomarkers to try to better understand the relationships between them and HIV infection.

Healthy volunteers and HIV-infected adults 18 years of age or older may be eligible for this study. Two visits are involved, as follows:

Visit 1 (screening visit to determine eligibility)

- Medical history and physical examination.

- Blood tests for HIV infection, blood counts, liver and kidney function.

- Pregnancy test for women who can become pregnant.

Visit 2

- Blood tests for hepatitis B and C

- Blood tests for markers of inflammation and blood clotting.

- Blood test for genetic changes that influence blood clotting.

In some cases, visits 1 and 2 may be combined.

Optional additional visits (up to 8 visits over 3 years)

- Additional blood draws for investigation of specific clinical or laboratory findings may be requested.

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- Age greater than or equal to 18 years

- Ability to understand and provide informed consent

- Adequate venous access

- Adequate blood counts (hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000 cells/mm(3))

- Willing and able to comply with study requirements and procedures including storage of blood samples for use in future studies of HIV, AIDS, immune function, inflammation, coagulation, and atherosclerosis

- Negative serum pregnancy test for females of child-bearing potential (female subjects who have medical documentation of hysterectomy and/or bilateral oophorectomy do not need to undergo pregnancy testing)

For HIV-negative subjects:

- No known history of HIV infection. At enrollment, HIV antibody testing will be performed to confirm negative HIV-1 antibody status.

For HIV-positive subjects:

- Established HIV diagnosis (previous documentation of HIV-1 infection in the subject s medical record; for subjects without such confirmation, positive ELISA testing confirmed by Western Blot or other confirmatory test, or plasma HIV viral load greater than 10,000 copies/mL)

- Must be under the care of a physician for HIV and general medical issues.

For HIV-positive subjects enrolling in the immunologic non-responder cohort:

-CD4 count less than 300 cells/mm(3) after two years of effective combination ART with documentation of viral suppression

-HIV viral load less than 50 copies/mL at screening, with no viral load greater than 1,000 copies/ml during the period of viral suppression.

-Not currently receiving any medication known to be associated with a low CD4 count

-No concurrent illness known to cause a low CD4 count

-Controls for this cohort will have a historical nadir CD4 count less than 300 cells/mm3, with current CD4 count greater than 300 cells/mm3 after three years of effective combination ART with documentation of viral suppression.


-Pregnant or breast-feeding

-Known bleeding or clotting disorder

-Current use of prescription anticoagulant including warfarin, low molecular weight heparin, clopidogrel or platelet aggregation inhibitor

-Concurrent malignancy requiring cytotoxic chemotherapy or radiation therapy

-Substance abuse or severe psychiatric disorder that would interfere with adherence to protocol requirements

-Any serious medical condition for which the principal investigator feels participation may be contraindicated

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Kuller LH, Tracy R, Belloso W, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Neuhaus J, Nixon D, Paton NI, Neaton JD; INSIGHT SMART Study Group. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection. PLoS Med. 2008 Oct 21;5(10):e203. doi: 10.1371/journal.pmed.0050203.

Borges AH, O'Connor JL, Phillips AN, Baker JV, Vjecha MJ, Losso MH, Klinker H, Lopardo G, Williams I, Lundgren JD; INSIGHT SMART Study Group; ESPRIT Study Group; SILCAAT Scientific Committee. Factors associated with D-dimer levels in HIV-infected individuals. PLoS One. 2014 Mar 13;9(3):e90978. doi: 10.1371/journal.pone.0090978. eCollection 2014.

Tenorio AR, Zheng Y, Bosch RJ, Krishnan S, Rodriguez B, Hunt PW, Plants J, Seth A, Wilson CC, Deeks SG, Lederman MM, Landay AL. Soluble markers of inflammation and coagulation but not T-cell activation predict non-AIDS-defining morbid events during suppressive antiretroviral treatment. J Infect Dis. 2014 Oct 15;210(8):1248-59. doi: 10.1093/infdis/jiu254. Epub 2014 May 1.

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Principal Investigator

Referral Contact

For more information:

Joseph A. Kovacs, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 496-9907

Mary McLaughlin, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 8C404
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8001

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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