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

NCT00002011 | Completed

• 1 other identifier: 049A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

PUVA Therapy; Methoxsalen; AIDS-Related Complex

Interventions

Methoxsalen DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Therakos: lead

Study Sites (1)

Morristown Memorial Hosp

Morristown, New Jersey, 07962, United States

Location

MeSH Terms

Conditions

HIV Infections; AIDS-Related Complex

Interventions

Methoxsalen

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1990-07

Locations

US (1)