Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057421
Status:
COMPLETED
Last Update Posted:
2007-09-18
First Post:
2003-04-01
Brief Title:
Tuberculosis in HIV Infected Patients in Uganda
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Impact of Tuberculosis on HIV Infection in Uganda
Status:
COMPLETED
Status Verified Date:
2007-08
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:
This was a clinical trial in HIV infected patients with tuberculosis The study assessed whether the addition of prednisolone a type of steroid medication to the standard treatment for tuberculosis improved immune and viral outcomes in the patients The study demonstrated that prednisolone increased the CD4 cell count as was hoped but the beneficial effect was short-lived and was gone within 4 months of stopping therapy Therefore the use of prednisolone for tuberculosis in HIV infected patients is not recommended at this time
Detailed Description:
Recent observations from retrospective cohort studies indicate that HIV-associated tuberculosis TB is associated with reduced survival and increased rate of opportunistic infections compared to CD4-matched controls Mounting evidence from immunologic and virologic studies supports the concept of co-pathogenesis in which cytokines such as tumor necrosis factor alpha TNF alpha are over-expressed during the course of TB and stimulate viral replication in latently infected cells possibly leading to greater viral load
Glucocorticoids are potent inhibitors of cytokines including TNF and clinicians have extensive experiences with their use in HIV infection Although corticosteroid use in HIV infection has a record of safety the safety and bioavailability of corticosteroids in HIVTB coinfection has not been established
This study evaluated the change in viral load and CD4 count in HIV infected patients with TB who were treated with oral prednisolone The study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly Although there was some benefit to using prednisolone in these patients the benefit was short-lived and was gone within 4 months of stopping therapy
Glucocorticoids are potent inhibitors of cytokines including TNF and clinicians have extensive experiences with their use in HIV infection Although corticosteroid use in HIV infection has a record of safety the safety and bioavailability of corticosteroids in HIVTB coinfection has not been established
This study evaluated the change in viral load and CD4 count in HIV infected patients with TB who were treated with oral prednisolone The study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly Although there was some benefit to using prednisolone in these patients the benefit was short-lived and was gone within 4 months of stopping therapy
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 |
|---|---|---|---|
| R01AI032414 | NIH | None | httpsreporternihgovquickSearchR01AI032414 |