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

June 23, 2005 updated by: Mallinckrodt
To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal photopheresis) in the Treatment of AIDS-Related Complex (ARC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have the following:

  • Diagnosis of AIDS-related complex (ARC).
  • Veins that can provide adequate access.
  • Negative drug screen for drugs of abuse and zidovudine (AZT).
  • Be willing to adhere to the protocol and sign a patient informed consent prior to study entry.
  • Live within adequate commuting distance to the treatment center.
  • Not be on any other investigational drug/device.
  • Be 18 - 80 years old but minimum age requirements may be affected by state regulations or specific medical conditions.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Inability to tolerate extracorporeal volume loss during the leukocyte-enrichment phase.
  • Photosensitive disease, such as porphyria or systemic lupus erythematosus. Care must be taken in selecting patients who require drugs (either systemically or topically) during the course of the study with photosensitizing potential such as phenothiazines, tetracyclines, sulfonamides or chlorothiazide.
  • Renal insufficiency with creatinine > 3 mg/dl.
  • Symptoms of toxic effects (World Health Organization Criteria) resulting from previous therapy.
  • Severe emotional, behavioral or psychiatric problems that in the opinion of the investigator would result in poor compliance with the treatment regimen.
  • Idiosyncratic or hypersensitivity reactions to 8-MOP compounds.
  • History of or active Pneumocystis carinii pneumonia, other opportunistic infection or neoplasms (Kaposi's sarcoma), or wasting syndrome.
  • Active hepatitis.
  • Aphakia because of the significantly increased risk of retinal damage due to absence of lenses.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT).
  • Photosensitizing drugs should not be administered prior to photopheresis treatment.
  • Other investigational drugs.

Concurrent Treatment:

Excluded:

  • Other treatment using an investigational device.

Patients with the following are excluded:

  • Inability to tolerate extracorporeal volume loss during the leukocyte-enrichment phase.
  • Photosensitive disease.
  • Symptoms of toxic effects (World Health Organization Criteria) resulting from previous therapy.
  • Severe emotional, behavioral or psychiatric problems that in the opinion of the investigator would result in poor compliance with the treatment regimen.
  • Idiosyncratic or hypersensitivity reactions to 8-MOP compounds.
  • Actively involved in drug abuse.
  • Aphakia because of the significantly increased risk of retinal damage due to absence of lenses.

Prior Medication:

Excluded:

  • Zidovudine (AZT).

Actively involved in drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 049A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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