Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002011
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex
Sponsor:
Mallinckrodt
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex
Status:
COMPLETED
Status Verified Date:
1990-07
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:
To determine the safety and patient tolerance of UVAR Photopheresis System extracorporeal photopheresis in the Treatment of AIDS-Related Complex ARC
Detailed Description:
Treatment involves the patient ingesting 8-methoxsalen 8-MOP by mouth approximately two hours prior to each photopheresis session The photopheresis instrument will separate the patients white blood cells and some plasma from other blood components and return the majority of blood components to the patient The separated white blood cells and plasma will be exposed to UVA Ultraviolet A light while outside the body The UVA light photoactivates the 8-MOP drug which is now located in the DNA of the collected cells After this exposure the patients photoactivated white blood cells will be returned to the patient by venous access
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?: