InflammationNCT00776412
Blood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults
An observational study of Inflammation and Pathologic Processes, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Inflammation, Pathologic Processes
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV positive patients and HIV negative healthy controls will be enrolled.
Who may be able to join
- 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)
Show all 17Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Biomarkers of Inflammation, Coagulation, and Endothelial Function in HIV-Infected Adults
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:
Read more
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.
Read the detailed description
D-dimer, a fibrin degradation product generated as a result of plasmin mediated clot dissolution processes, is an indicator of recent clot formation and subsequent fibrinolysis. Analysis of D-dimer concentration is employed in the diagnosis of deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. More recently, D-dimer levels have been correlated with atherosclerotic cardiovascular disease. In a recent case-control study of biomarkers for cardiovascular disease in human immunodeficiency virus (HIV)-infected adults, baseline D-dimer levels strongly correlated with all-cause mortality. Notably, the association between baseline D-dimer levels and death due to cardiovascular disease was less significant.
At present, the pathophysiology underlying the association of elevated D-dimer concentrations with mortality in HIV is not understood. This study seeks to identify possible mechanisms underlying D-dimer elevations in HIV-infected adults by investigating a number of pathways that may be associated with the elevations using biomarkers of inflammation, hemostasis, thrombosis, platelet function, lipid metabolism, and additional indicators of endothelial function. Further elucidation of plausible pathways contributing to D-dimer elevation could, ultimately, lead to trials of risk-reducing interventions for patients with an elevated D-dimer level.
This study, an exploratory, cross-sectional study of up to 350 subjects, seeks to prospectively collect data on D-dimer and related biomarkers in HIV-infected adults. Initially, the study will recruit HIV-infected adults with HIV viremia who are not taking antiretroviral therapy (ART) and compare their clinical histories and biomarker findings with those from (1) a group of HIV-infected adults with controlled HIV viremia who are receiving ART, and with those from (2) a control group of HIV-negative healthy subjects. Additionally, to study the impact of persistent immune activation and inflammation on immune responses to ART, a cohort of HIV-infected adults with poor CD4+ cell recovery despite effective ART, and to better understand the mechanisms that contribute to impaired immunologic recovery, a cohort of HIV-infected adults with poor CD4+ cell recovery despite effective ART will be enrolled (immunologic non-responder cohort) and for comparison, a control group with similar nadir CD4 counts but with good CD4+ cell recovery on ART.
The study requires 2 visits for screening, history and physical examination, and phlebotomy. A wide array of research assays investigating different aspects of inflammation, coagulation, and endothelial function will be completed. Samples will be stored for future investigation.
- Conditions
- Inflammation, Pathologic Processes
- Keywords
- Immunologic Non-Responder, Cardiovascular Disease, Antiretroviral, Mortality, Natural History, HIV Positive, HIV Negative, Healthy Volunteer, HV
- Medical subject headings
- Inflammation, Pathologic Processes, Cardiovascular Diseases, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV negative | Healthy Volunteer cohort | |
| HIV positive INR | HIV positive INR cohort | |
| HIV positive Standard | HIV positive Standard cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cross-sectional and longitudinal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study start20 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joseph A Kovacs, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776412
- Sponsor's protocol ID
- 090013
- Other IDs
- 09-I-0013
- Status last verified
- 12 Feb 2026
- First submitted
- 18 Oct 2008
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18942885Borges 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.
PubMed 24626096Tenorio 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.
PubMed 24795473
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Inflammation, Coagulation, and Endothelial Function in HIV-Infected Adults
- ClinicalTrials.gov ID
- NCT00776412
- Acronym / sponsor ID
- 090013
- Conditions
- Inflammation, Pathologic Processes
- Keywords
- Immunologic Non-Responder, Cardiovascular Disease, Antiretroviral, Mortality, Natural History, HIV Positive, HIV Negative, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Nov 2008 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
D-dimer, a fibrin degradation product generated as a result of plasmin mediated clot dissolution processes, is an indicator of recent clot formation and subsequent fibrinolysis. Analysis of D-dimer concentration is employed in the diagnosis of deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. More recently, D-dimer levels have been correlated with atherosclerotic cardiovascular disease. In a recent case-control study of biomarkers for cardiovascular disease in human immunodeficiency virus (HIV)-infected adults, baseline D-dimer levels strongly correlated with all-cause mortality. Notably, the association between baseline D-dimer levels and death due to cardiovascular disease was less significant.
At present, the pathophysiology underlying the association of elevated D-dimer concentrations with mortality in HIV is not understood. This study seeks to identify possible mechanisms underlying D-dimer elevations in HIV-infected adults by investigating a number of pathways that may be associated with the elevations using biomarkers of inflammation, hemostasis, thrombosis, platelet function, lipid metabolism, and additional indicators of endothelial function. Further elucidation of plausible pathways contributing to D-dimer elevation could, ultimately, lead to trials of risk-reducing interventions for patients with an elevated D-dimer level.
This study, an exploratory, cross-sectional study of up to 350 subjects, seeks to prospectively collect data on D-dimer and related biomarkers in HIV-infected adults. Initially, the study will recruit HIV-infected adults with HIV viremia who are not taking antiretroviral therapy (ART) and compare their clinical histories and biomarker findings with those from (1) a group of HIV-infected adults with controlled HIV viremia who are receiving ART, and with those from (2) a control group of HIV-negative healthy subjects. Additionally, to study the impact of persistent immune activation and inflammation on immune responses to ART, a cohort of HIV-infected adults with poor CD4+ cell recovery despite effective ART, and to better understand the mechanisms that contribute to impaired immunologic recovery, a cohort of HIV-infected adults with poor CD4+ cell recovery despite effective ART will be enrolled (immunologic non-responder cohort) and for comparison, a control group with similar nadir CD4 counts but with good CD4+ cell recovery on ART.
The study requires 2 visits for screening, history and physical examination, and phlebotomy. A wide array of research assays investigating different aspects of inflammation, coagulation, and endothelial function will be completed. Samples will be stored for future investigation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV negative | – | –Healthy Volunteer cohort |
| HIV positive INR | – | –HIV positive INR cohort |
| HIV positive Standard | – | –HIV positive Standard cohort |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive patients and HIV negative healthy controls will be enrolled.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Cross-sectional and longitudinal
The findings of this exploratory study will be used to generate hypotheses for future research studies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 18942885Kuller 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.
- Background: PubMed 24626096Borges 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.
- Background: PubMed 24795473Tenorio 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Kovacs, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Pathologic Processes, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Cross-sectional and longitudinal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.