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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002011
• Other study ID #: 049A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal photopheresis) in the Treatment of AIDS-Related Complex (ARC).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS-Related Complex
• HIV Infections

Intervention

Drug:
• Methoxsalen

Locations

Country	Name	City	State
United States	Morristown Memorial Hosp	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Therakos

Country where clinical trial is conducted

United States,