Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients
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|ClinicalTrials.gov Identifier: NCT00039689|
Recruitment Status : Recruiting
First Posted : June 7, 2002
Last Update Posted : March 27, 2023
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There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication and normalization of immune function, and natural killer function relative to HIV disease.
Study participants will be adult (older than 18 years) HIV primary or acutely affected patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease) and HIV chronically infected patients (those infected with HIV for longer than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women will not be enrolled in the study; women who become pregnant will be dropped from the study.
Leukapheresis will be performed on each patient before HAART therapy begins and then three times a year. Each session will take between 1 and 3 hours.
This longitudinal study will enable researchers to examine the function of certain B cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral-Naive HIV-Infected Patients|
|Actual Study Start Date :||July 12, 2002|
HIV chronic infection
For example, an individual infected with HIV-1 for an indeterminate amount of time.
HIV early infection
For example, a negative HIV antibody immunoassay within 6 months of a positive HIV antibody assay and confirmatory test (as defined by current CDC criteria).
- To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients [ Time Frame: Throughout the study ]To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with early HIV infection.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- INCLUSION CRITERIA:
Adult (18 years old or older) HIV-1-infected patient
Adequate venous access for apheresis or sufficient research blood collection
Positive HIV antibody immunoassay and a positive confirmatory HIV test (as defined by current CDC criteria). Tests may be done in our clinic or by an outside provider. For individuals with suspected early infection; the following additional criteria may be used: HIV RNA levels of >2,000 copies/ml with a negative result from an HIV antibody immunoassay.
Willingness to be able to make follow up visits at least once in the next 4 months and prior to the initiation of antiretroviral therapy.
Blood pressure less than 180/100; pulse rate between 50-100 unless a lower pulse reat is considered normal for the volunteer
Adequate blood counts (hemoglobin greater than or equal to 9.0 g/dL, hematocrit greater than or equal to 28 percent, platelets greaterhan or equal to 50,000).
Willingness to give informed consent including consent for the storage of blood samples and genetic testing.
Antiretroviral naive or no antiretroviral use in the last six months, or previously enrolled 02-I-0202 subjects on whom there are samples stored in the repository. Subjects who become HIV- infected
while taking antiretroviral therapy for pre-exposure prophylaxis (PrEP) will be eligible for enrollment as long as them meet diagnostic criteria for HIV positivity. Subjects who enroll under another LIR apheresis protocol within the past three months and complete
the apheresis prior to starting antiretroviral therapy will also be
eligible for enrollment.
Pregnant and/or breastfeeding women.
Be currently acusing alcohol or other drugs that potentially could interfere with patient compliance or safety.
Have a condition in the opinion of the investigators would make the patient ineligible for the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039689
|Contact: Kathleen R Gittens||(301) email@example.com|
|Contact: Susan Moir, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 email@example.com|
|Principal Investigator:||Susan Moir, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||June 7, 2002 Key Record Dates|
|Last Update Posted:||March 27, 2023|
|Last Verified:||February 22, 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Chronic HIV Infection
Primary HIV Infection