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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methoxsalen
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring PUVA Therapy, Methoxsalen, AIDS-Related Complex

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Morristown Memorial Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00002011
Brief Title
The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex
Official Title
The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex
Study Type
Interventional

2. Study Status

Record Verification Date
July 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mallinckrodt

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
PUVA Therapy, Methoxsalen, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methoxsalen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Morristown Memorial Hosp
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States

12. IPD Sharing Statement

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