MedTrace Logo

RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART)

NCT00157027 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-01-16

No results posted yet for this study

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 CD4/CD8 ratio;
* Evaluate the effects of this therapy on the patient's immune system, by skin reactivity to a standard anergy panel.

Conditions

  • HIV Infections

Interventions

PROCEDURE

Extracorporeal photochemotherapy with UVADEX

Photopheresis (or extracorporeal photoimmunetherapy \[ECP\]) 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.

Sponsors & Collaborators

  • Therakos

    collaborator INDUSTRY

  • Atlantic Health System

    lead OTHER

Principal Investigators

  • Emil Bisaccia, MD · Morristown Memorial Hospital-Atlantic Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Completion
2010-04-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00157027 on ClinicalTrials.gov