Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157027
Status:
WITHDRAWN
Last Update Posted:
2014-01-16
First Post:
2005-09-08
Brief Title:
RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy HAART
Sponsor:
Atlantic Health System
Organization:
Atlantic Health System
Study Overview
Official Title:
The Use of Extracorporeal Photochemotherapy With UVADEX in Patients With HIV Who Are Refractory or Intolerant to HAART
Status:
WITHDRAWN
Status Verified Date:
2014-01
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:
HIV-HAART
Brief Summary:
The objectives of this clinical trial are to
Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing agent Uvadex in the treatment of HIV-1 infection
Evaluate the effects of this therapy on HIV-1 viral load by polymerase chain reaction PCR analysis
Evaluate the effects of this therapy on CD4 CD8 cells and CD4CD8 ratio
Evaluate the effects of this therapy on the patients immune system by skin reactivity to a standard anergy panel
Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing agent Uvadex in the treatment of HIV-1 infection
Evaluate the effects of this therapy on HIV-1 viral load by polymerase chain reaction PCR analysis
Evaluate the effects of this therapy on CD4 CD8 cells and CD4CD8 ratio
Evaluate the effects of this therapy on the patients immune system by skin reactivity to a standard anergy panel
Detailed Description:
Rationale for the Use of ECP with UVADEX in Patients with HIV-1 Infection
Studies have demonstrated that psoralen and ultraviolet A light inactivate HIV virus in vitro Edelson et al showed that extracorporeal photochemotherapy ECP with psoralen primarily targets the CD4 cell the population predominately affected by HIV-1 infection It is postulated that the re-infusion of the ECP treated cell fraction free virus cell-associated virus along with whole cells cell fragments and soluble antigens may serve to engender a specific HIV immune response
A twenty-patient study using ECP with psoralen was conducted by Bisaccia et al In this study patients were HIV positive by enzyme linked immunosorbent assay and these positive results were confirmed by Western blot test Patients were staged as Walter Reed class WR3 to WR5 Extracorporeal photoimmune therapy was administered on two consecutive days on a monthly basis for 6-29 months This study reported that CD4 counts declined more slowly than historical controls Walter Reed classification improved in 55 1120 was stable in 35 720 and declined in 10 220 of the patients treated in this study
One measure in the in vivo evaluation of T-cell function is provided by skin reactivity to recall antigens DTH A lack of this response has been associated with progression of HIV disease In the Bisaccia study skin reactivity to recall antigens DTH improved in 55 1120 patients were stable in 35 720 progressed to anergy in 5 120 One patient was initially anergic and remained anergic post-treatment Following treatment with ECP 60 915 displayed normal skin test responses whereas the baseline examinations had been normal in only 5 119 In addition 21 419 of patients showed a partial skin test response Only 10 220 of patients developed a new opportunistic infection This included the patient initially anergic and who remained anergic and the patient who progressed to anergy post-ECP treatment
DESCRIPTION OF THE UVAR XTSÔ PHOTOPHERESIS SYSTEM
Photopheresis or extracorporeal photoimmune therapy ECP is a process developed by THERAKOS Inc a Johnson and Johnson Company During the process of ECP whole blood is drawn from the patient over several cycles centrifuged and separated into the components of plasma white cells or buffy coat and red blood cells A portion of the white cells and the plasma are saved in a separate compartment The remaining plasma and red blood cells are immediately returned to the patient
The saved buffy coat white blood cells and plasma are inoculated with the photosensitizing agent UVADEX Photoactivation begins when the suspension is exposed to a prescribed amount of ultraviolet-A light After photoactivation is complete the treated suspension is returned to the patient
Photopheresis performed using the UVAR XTS is a continuous process During the entire therapy the patient remains connected to the photopheresis instrument The duration of time between completion of the buffy coat collection and reinfusion of the light-activated buffy coat is approximately 30 minutes
Studies have demonstrated that psoralen and ultraviolet A light inactivate HIV virus in vitro Edelson et al showed that extracorporeal photochemotherapy ECP with psoralen primarily targets the CD4 cell the population predominately affected by HIV-1 infection It is postulated that the re-infusion of the ECP treated cell fraction free virus cell-associated virus along with whole cells cell fragments and soluble antigens may serve to engender a specific HIV immune response
A twenty-patient study using ECP with psoralen was conducted by Bisaccia et al In this study patients were HIV positive by enzyme linked immunosorbent assay and these positive results were confirmed by Western blot test Patients were staged as Walter Reed class WR3 to WR5 Extracorporeal photoimmune therapy was administered on two consecutive days on a monthly basis for 6-29 months This study reported that CD4 counts declined more slowly than historical controls Walter Reed classification improved in 55 1120 was stable in 35 720 and declined in 10 220 of the patients treated in this study
One measure in the in vivo evaluation of T-cell function is provided by skin reactivity to recall antigens DTH A lack of this response has been associated with progression of HIV disease In the Bisaccia study skin reactivity to recall antigens DTH improved in 55 1120 patients were stable in 35 720 progressed to anergy in 5 120 One patient was initially anergic and remained anergic post-treatment Following treatment with ECP 60 915 displayed normal skin test responses whereas the baseline examinations had been normal in only 5 119 In addition 21 419 of patients showed a partial skin test response Only 10 220 of patients developed a new opportunistic infection This included the patient initially anergic and who remained anergic and the patient who progressed to anergy post-ECP treatment
DESCRIPTION OF THE UVAR XTSÔ PHOTOPHERESIS SYSTEM
Photopheresis or extracorporeal photoimmune therapy ECP is a process developed by THERAKOS Inc a Johnson and Johnson Company During the process of ECP whole blood is drawn from the patient over several cycles centrifuged and separated into the components of plasma white cells or buffy coat and red blood cells A portion of the white cells and the plasma are saved in a separate compartment The remaining plasma and red blood cells are immediately returned to the patient
The saved buffy coat white blood cells and plasma are inoculated with the photosensitizing agent UVADEX Photoactivation begins when the suspension is exposed to a prescribed amount of ultraviolet-A light After photoactivation is complete the treated suspension is returned to the patient
Photopheresis performed using the UVAR XTS is a continuous process During the entire therapy the patient remains connected to the photopheresis instrument The duration of time between completion of the buffy coat collection and reinfusion of the light-activated buffy coat is approximately 30 minutes
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