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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001110 |
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.
Condition | Intervention |
HIV Infections |
Procedure: Bronchoalveolar lavage |
MedlinePlus related topics: | AIDS AIDS Medicines |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Effect of Highly Active Antiretroviral Therapy (HAART) on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects |
Estimated Enrollment: | 50 |
Study Start Date: | August 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, Indiana | |||||
Indiana Univ Hosp | |||||
Indianapolis, Indiana, United States, 462025250 | |||||
United States, New York | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
United States, Ohio | |||||
Univ of Cincinnati | |||||
Cincinnati, Ohio, United States, 452670405 | |||||
United States, Pennsylvania | |||||
Univ of Pennsylvania at Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
Puerto Rico | |||||
Univ of Puerto Rico | |||||
San Juan, Puerto Rico, 009365067 |
Study Chair: | HL Twigg | |
Study Chair: | J Wheat |
Haga clic aquí para ver información sobre este ensayo clínico en español. 
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Study ID Numbers: | ACTG 723, AACTG 723 |
First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00001110 |
Health Authority: | United States: Federal Government |
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