The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002011
• Lead Sponsor: Mallinckrodt

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 patient's 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 Timeline

• Status Verified: 1990-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Morristown Memorial Hosp; 🇺🇸 Morristown, New Jersey, United States