Status:
COMPLETED
Blood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Inflammation
Pathologic Processes
Eligibility:
All Genders
18-100 years
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 hav...
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 co...
Eligibility Criteria
Inclusion
- 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 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.
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
November 20 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00776412
Start Date
November 20 2008
Last Update
October 2 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892