This study is currently recruiting participants.
Number
09-I-0013
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Enrolling by Invitation Gender: Male & Female Min Age: 18 Years Max Age: 100 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Immunologic Non-Responder; Cardiovascular Disease; Antiretroviral; Mortality; Natural History
Recruitment Keyword(s)
HIV Positive; HIV Negative; Healthy Volunteer; HV
Condition(s)
Inflammation; Pathologic Processes
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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.
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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
- 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
Principal Investigator
Referral Contact
For more information: