Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000880
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Study of Cyclosporin Neoral in Immune Activation and HIV Expression in Early HIV Disease
Status:
COMPLETED
Status Verified Date:
2021-10
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 determine the safety and effectiveness of low doses of cyclosporine CsA in patients with early HIV infection and to evaluate its effect on the immune system
Activation of T cells cells of the immune system leads to HIV replication Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection CsA is capable of decreasing T cell activation which in turn may decrease HIV replication
Activation of T cells cells of the immune system leads to HIV replication Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection CsA is capable of decreasing T cell activation which in turn may decrease HIV replication
Detailed Description:
There is increasing data on the potential for inhibition of immune activation as primary therapy for HIV infection The rationale of CsA therapy is to decrease T cell activation in patients with early HIV infection Activation of T cells leads to translation and transcription of provirus release of viral progeny and ultimately cell death T cell activation also leads to increased cell death via apoptosis CsA is capable of inhibiting both these events and thus may lead to decreased CD4 cell turnover
This study has 2 arms of 15 patients each Patients in Arm I receive placebo Patients in Arm II receive CsA Each arm is further divided into 2 strata Stratum 1 patients are not allowed to receive antiretroviral therapy Stratum 2 patients must receive 1 of the following 4 stable nucleoside analogue combinations
1 Zidovudine ZDV plus lamivudine 3TC
2 ZDV plus didanosine ddI
3 Stavudine d4T plus 3TC
4 d4T plus ddI
This study has 2 arms of 15 patients each Patients in Arm I receive placebo Patients in Arm II receive CsA Each arm is further divided into 2 strata Stratum 1 patients are not allowed to receive antiretroviral therapy Stratum 2 patients must receive 1 of the following 4 stable nucleoside analogue combinations
1 Zidovudine ZDV plus lamivudine 3TC
2 ZDV plus didanosine ddI
3 Stavudine d4T plus 3TC
4 d4T plus ddI
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 |
|---|---|---|---|
| 11306 | REGISTRY | DAIDS ES | None |