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

NCT ID: NCT00002011

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

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

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Methoxsalen

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therakos

INDUSTRY

Sponsor Role: lead

Locations

Morristown Memorial Hosp

Morristown, New Jersey, United States

Countries

United States

Other Identifiers

049A

Identifier Type: -

Identifier Source: org_study_id