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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002011
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal photopheresis) in the Treatment of AIDS-Related Complex (ARC).

Condition Intervention
HIV Infections Drug: Methoxsalen

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002011


Locations
United States, New Jersey
Morristown Memorial Hosp
Morristown, New Jersey, United States, 07962
Sponsors and Collaborators
Mallinckrodt
  More Information

ClinicalTrials.gov Identifier: NCT00002011     History of Changes
Other Study ID Numbers: 049A
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: July 1990

Keywords provided by NIH AIDS Clinical Trials Information Service:
PUVA Therapy
Methoxsalen
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
AIDS-Related Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Methoxsalen
Photosensitizing Agents
Dermatologic Agents