HIV Infection Clinical Trial
Official title:
Studies of Lymphocyte Kinetics Using Bromodeoxyuridine
This study will examine how quickly white blood cells called CD4 lymphocytes reproduce and
how long they live in people infected with HIV. It will do this using bromodeoxyuridine
(BrDU), a compound that is structurally similar to thymidine, one of the building blocks of
DNA. BrDU gets incorporated into DNA instead of thymidine, but it can only get into cells
that are replicating. Therefore, measuring the proportion of cells with BrDU indicates how
many cells are replicating.
HIV-infected patients 18 years of age and older may be eligible for this study. Candidates
will be screened with a medical history, physical examination, chest X-ray, electrocardiogram
(EKG) and blood tests.
Participants will be given an infusion of BrDU through a catheter (thin plastic tube) placed
in an arm vein. Blood will be drawn up to 4 times in the first 24 hours after the infusion.
Additional samples will then be collected as often as daily for the first week, twice a week
for the next 3 weeks and then weekly to monthly for up to 1 year. Some patients may undergo a
tissue biopsy (removal of a small tissue sample from a lymph node, tonsil or colon) or
computed tomography (CT) scans of the thymus (a small gland between the lungs that
manufactures lymphocytes. Some patients will have a second infusion in order to examine
changes in the rate of CD4 replication over time or following potent antiretroviral therapy.
Patients will be followed in the clinic periodically for the first year and then will be seen
in the clinic or contacted by telephone once a year for 4 more years.
The results of this study may provide a better understanding of how HIV causes disease and
how therapy affects the immune system.
Understanding the rate of lymphocyte replication and destruction in HIV infected patients, as well as the effects of therapy on lymphocyte replication should lead to a better understanding of the mechanisms behind the immunodeficiency induced by HIV. To examine this directly, up to 85 HIV-infected patients will be enrolled in the study. Patients will receive up to two 30 minute infusions (at least one month apart) of bromodeoxyuridine (BrDU; 200 mg/m(2)), an analogue of thymidine. BrDU is incorporated into DNA and can be measured using an anti-BrDU monoclonal antibody. It can be measured in subpopulations of cells to determine the rate of replication of those cells. All participants in this study will be reimbursed for the inconvenience and discomfort associated with study participation. ;
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