Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000921
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
1999-11-02
Brief Title:
The Effects of Prednisone on HIV Levels and the Immune System
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2003-06
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 if it is safe and effective to give prednisone to HIV-infected patients
Prednisone is a corticosteroid a hormone produced by the body that inhibits immune cell responses Prednisone may be able to lower the level of HIV in the body viral load by reducing the number of cells that HIV can infect At the same time prednisone may be able to increase CD4 cell counts cells of the immune system that fight infection
Prednisone is a corticosteroid a hormone produced by the body that inhibits immune cell responses Prednisone may be able to lower the level of HIV in the body viral load by reducing the number of cells that HIV can infect At the same time prednisone may be able to increase CD4 cell counts cells of the immune system that fight infection
Detailed Description:
By inhibiting cellular activation corticosteroids such as prednisone may inhibit HIV expression and reduce the population of potentially infectable cells Furthermore no studies have been performed to systematically evaluate immune function in prednisone-treated HIV-infected patients or the immune mechanisms that may facilitate increases in CD4 cell number This study explores this issue
Patients are separated into 2 arms according to whether or not they are currently receiving a protease inhibitor PI as part of their antiretroviral ARV therapy regimen PI vs no PI therapy Arm I Current stable ARV therapy plus prednisone for 8 weeks followed by 4 weeks at half the prior dose then a 2-week taper Arm II Current stable ARV therapy plus prednisone placebo for 12 weeks
Patients are separated into 2 arms according to whether or not they are currently receiving a protease inhibitor PI as part of their antiretroviral ARV therapy regimen PI vs no PI therapy Arm I Current stable ARV therapy plus prednisone for 8 weeks followed by 4 weeks at half the prior dose then a 2-week taper Arm II Current stable ARV therapy plus prednisone placebo for 12 weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: