- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000945
A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients
A Pilot Study of the Effect of Cidofovir for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in Subjects With Acquired Immunodeficiency Syndrome (AIDS)
The purpose of this study is to evaluate the safety, tolerance, and overall effectiveness of cidovir to treat PML in AIDS patients.
PML is an opportunistic infection (HIV-associated, due to weak immune system) caused by a virus that attacks the brain. Cidovir has been used effectively to treat cytomegalovirus (CMV) of the eye. Cidovir could be an effective treatment for PML as well.
Study Overview
Status
Intervention / Treatment
Detailed Description
PML is a demyelinating disease of the brain's white matter, occurring when the JC virus infects the brain of patients infected with HIV-1. Cidofovir is known to be an effective treatment for cytomegalovirus of the eye and, in laboratory and animal testing, has also been shown to be effective against several other viruses. However, cidofovir is considered investigational as a treatment for PML.
In this multicenter, open-label study 24 patients receive cidofovir iv over 1 hr on days 0, 7, then every 2 wk for a total of 13 doses.
Oral probenecid is given 3h prior to and 2h and 8h following cidofovir administration. Nucleoside and non-nucleoside reverse transcriptors are withheld on days of probenecid administration. Protease inhibitors are continued during probenecid administration.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham
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California
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San Francisco, California, United States, 941102859
- San Francisco AIDS Clinic / San Francisco Gen Hosp
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San Francisco, California, United States, 941102859
- San Francisco Gen Hosp
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Colorado
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Denver, Colorado, United States, 80262
- Univ of Colorado Health Sciences Ctr
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District of Columbia
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Washington, District of Columbia, United States, 20059
- Howard Univ
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, United States, 60612
- Cook County Hosp
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Chicago, Illinois, United States, 60640
- Louis A Weiss Memorial Hosp
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
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New York
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Buffalo, New York, United States, 14215
- SUNY / Erie County Med Ctr at Buffalo
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 275997215
- Univ of North Carolina
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Ohio
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Cincinnati, Ohio, United States, 45267
- Univ of Kentucky Lexington
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South Carolina
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West Columbia, South Carolina, United States, 29169
- Julio Arroyo
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Washington
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Seattle, Washington, United States, 98104
- Univ of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Have had symptoms of PML for no more than 90 days before study entry, or have had abnormal neurological exams related to PML.
- Have negative tests for bacterial or fungal infections.
- Agree to practice abstinence or use effective methods of birth control during the study.
- Are at least 18 years old.
- Have a life expectancy of at least 6 months.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of uveitis.
- Are allergic to sulfa drugs or probenecid.
- Have had active opportunistic infections other than Kaposi's sarcoma within 30 days before study entry.
- Have sickle cell anemia or trait.
- Are pregnant or breast-feeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Marra CM
- Study Chair: Barker DE
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Demyelinating Diseases
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- DNA Virus Infections
- Slow Virus Diseases
- HIV Infections
- Encephalitis
- Polyomavirus Infections
- Acquired Immunodeficiency Syndrome
- Leukoencephalopathy, Progressive Multifocal
- Leukoencephalopathies
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Gout Suppressants
- Renal Agents
- Uricosuric Agents
- Cidofovir
- Probenecid
Other Study ID Numbers
- ACTG 363
- 11327 (Registry Identifier: DAIDS ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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