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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002011
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1990
  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: Endpoint Classification: Safety Study
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
AIDS-Related Complex
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Methoxsalen
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014