HIV study probes hidden clot risks

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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