Effect of Anti-HIV Therapy (HAART) on HIV Levels in the Lungs and on Lung Cell Inflammation in HIV-Infected Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001110|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : July 29, 2013
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 or disease||Intervention/treatment|
|HIV Infections||Procedure: Bronchoalveolar lavage|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Effect of Highly Active Antiretroviral Therapy (HAART) on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects|
|Study Start Date :||August 1999|
|Study Completion Date :||April 2003|
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): NCT00001110
|United States, Indiana|
|Indiana Univ. School of Medicine, Infectious Disease Research Clinic|
|Indianapolis, Indiana, United States, 462025250|
|United States, New York|
|NY Univ. HIV/AIDS CRS|
|New York, New York, United States, 10016|
|United States, Ohio|
|Univ. of Cincinnati CRS|
|Cincinnati, Ohio, United States, 452670405|
|United States, Pennsylvania|
|Hosp. of the Univ. of Pennsylvania CRS|
|Philadelphia, Pennsylvania, United States, 19104|
|Puerto Rico-AIDS CRS|
|San Juan, Puerto Rico, 009365067|
|Study Chair:||HL Twigg|
|Study Chair:||J Wheat|