NCT00776412

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

Completed Last updated 14 April 2026

What this trial tests

trial in Inflammation in 310 participants. Completed.

Timeline

20 November 2008

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	310
Start date	20 November 2008
Sites	1 location across United States

Conditions studied

• Inflammation — all drugs for Inflammation →
• Pathologic Processes — all drugs for Pathologic Processes →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 100, any sex, with Inflammation or Pathologic Processes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. What happens to cardiovascular system behind the undetectable level of HIV viremia?
   d'Ettorre G, Ceccarelli G, Pavone P, Vittozzi P, et al · · 2016 · cited 27× · PMID 27127532 · DOI 10.1186/s12981-016-0105-z