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

This study has been completed.

Sponsored by: Therakos
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002011
  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

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Methoxsalen   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex

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
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002011

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

Sponsors and Collaborators
Therakos
  More Information


Study ID Numbers:   049A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002011
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Methoxsalen
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Photosensitizing Agents
RNA Virus Infections
Slow Virus Diseases
Radiation-Sensitizing Agents
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Lentivirus Infections
Infection
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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