HIV Infections Clinical Trial
Official title:
Effect of Highly Active Antiretroviral Therapy (HAART) on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects
The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that
in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces
lung inflammation in HIV-infected patients.
Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these
cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the
lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates
a high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is
able to decrease viral load in the lungs, it should also be able to decrease lung-cell
inflammation in these patients.
Lymphocytic alveolitis in HIV-infected patients probably represents a local immune response
to HIV-infected cells in the lung. The intensity of lymphocytic alveolitis may therefore
reflect the viral load in the lung. If so, treatment that reduces viral load in the lung
(e.g., HAART) should also decrease the number of cytotoxic T lymphocytes (CTLs) in the
alveolar space and should return pulmonary immune responses toward normal.
Patients are stratified by CD4 count: less than 200 cells/mm3 or 200 - 500 cells/mm3. BAL is
performed and blood samples are collected prior to initiation of HAART and after 1 and 6
months of HAART. If a patient has detectable HIV in the lung after 6 months of HAART, the
patient is asked to submit to an optional fourth BAL after 12 months of HAART. BAL fluid and
cells are analyzed for HIV viral load, percent lymphocytes, and lymphocyte subsets.
Responses in the lung are compared to simultaneous changes in these variables found in the
peripheral blood. Each patient serves as his/her own control.
;
Primary Purpose: Treatment
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