Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001110
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
1999-11-02
Brief Title:
Effect of Anti-HIV Therapy HAART on HIV Levels in the Lungs and on Lung Cell Inflammation in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effect of Highly Active Antiretroviral Therapy HAART on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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
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 ie 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
Detailed Description:
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 eg 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 cellsmm3 or 200 - 500 cellsmm3 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 hisher own control
Patients are stratified by CD4 count less than 200 cellsmm3 or 200 - 500 cellsmm3 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 hisher own control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10188 | REGISTRY | DAIDS-ES | None |
| AACTG 723 | None | None | None |