Protocol Number: 09-I-0013

Title:

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

Number:

09-I-0013

Summary:

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

- 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 plasma HIV viral load greater than 10,000 copies/mL)

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

EXCLUSION CRITERIA:

-Pregnant or breast-feeding

-Known bleeding or clotting disorder including history of deep vein thrombosis, pulmonary embolism, or hemophilia

-Current use of warfarin, low molecular weight heparin, clopidogrel or experimental 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

Special Instructions:

Currently Not Provided

Keywords:

Cardiovascular Disease

D-dimer

Antiretroviral

Mortality

Recruitment Keyword(s):

HIV Positive

HIV Negative

Healthy Volunteer

HV

Condition(s):

Cardiovascular Disease

HIV Infections

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Chan SY, Mancini GB, Kuramoto L, Schulzer M, Frohlich J, Ignaszewski A. The prognostic importance of endothelial dysfunction and carotid atheroma burden in patients with coronary artery disease. J Am Coll Cardiol. 2003 Sep 17;42(6):1037-43.

Fathi R, Haluska B, Isbel N, Short L, Marwick TH. The relative importance of vascular structure and function in predicting cardiovascular events. J Am Coll Cardiol. 2004 Feb 18;43(4):616-23.

Shimbo D, Grahame-Clarke C, Miyake Y, Rodriguez C, Sciacca R, Di Tullio M, Boden-Albala B, Sacco R, Homma S. The association between endothelial dysfunction and cardiovascular outcomes in a population-based multi-ethnic cohort. Atherosclerosis. 2007 May;192(1):197-203

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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