Blood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults

NCT00776412 | Completed

• 2 other identifiers: 09001309-I-0013
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Pathologic Processes

Keywords

Immunologic Non-Responder; Cardiovascular Disease; Antiretroviral; Mortality; Natural History; HIV Positive; HIV Negative; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Obtain blood samples for further investigation into the correlation between markers of coagulation, including D-dimer, and markers of platelet function, inflammation, endothelial cell function, and clinical parameters in HIV-infected adults.

  The findings of this exploratory study will be used to generate hypotheses for future research studies.

  Cross-sectional and longitudinal

Study Arms (3)

HIV negative

Healthy Volunteer cohort

HIV positive INR

HIV positive INR cohort

HIV positive Standard

HIV positive Standard cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV positive patients and HIV negative healthy controls will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 18942885 BACKGROUND

• 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.

  PMID: 24626096 BACKGROUND

• 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.

  PMID: 24795473 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Inflammation; Pathologic Processes; Cardiovascular Diseases; HIV Seropositivity

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Joseph A Kovacs, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2008
• First Posted: October 21, 2008
• Study Start: November 20, 2008
• Last Updated: May 7, 2026

Record last verified: 2026-02-12

Locations

US (1)