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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000945 |
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.
Condition | Intervention |
HIV Infections Leukoencephalopathy, Progressive Multifocal |
Drug: Cidofovir Drug: Probenecid |
MedlinePlus related topics: | AIDS Neurologic Diseases |
Drug Information available for: | Probenecid Cidofovir |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Pilot Study of the Effect of Cidofovir for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in Subjects With Acquired Immunodeficiency Syndrome (AIDS) |
Estimated Enrollment: | 24 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, Alabama | |||||
Univ of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, California | |||||
San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
San Francisco AIDS Clinic / San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
United States, Colorado | |||||
Univ of Colorado Health Sciences Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
United States, District of Columbia | |||||
Howard Univ | |||||
Washington, District of Columbia, United States, 20059 | |||||
United States, Illinois | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
Rush Presbyterian - Saint Luke's Med Ctr | |||||
Chicago, Illinois, United States, 60612 | |||||
Cook County Hosp | |||||
Chicago, Illinois, United States, 60612 | |||||
Louis A Weiss Memorial Hosp | |||||
Chicago, Illinois, United States, 60640 | |||||
United States, Maryland | |||||
Johns Hopkins Hosp | |||||
Baltimore, Maryland, United States, 21287 | |||||
United States, New York | |||||
Univ of Rochester Medical Center | |||||
Rochester, New York, United States, 14642 | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
Mount Sinai Med Ctr | |||||
New York, New York, United States, 10029 | |||||
SUNY / Erie County Med Ctr at Buffalo | |||||
Buffalo, New York, United States, 14215 | |||||
Beth Israel Med Ctr | |||||
New York, New York, United States, 10003 | |||||
United States, North Carolina | |||||
Univ of North Carolina | |||||
Chapel Hill, North Carolina, United States, 275997215 | |||||
United States, Ohio | |||||
Univ of Kentucky Lexington | |||||
Cincinnati, Ohio, United States, 45267 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 | |||||
United States, Washington | |||||
Univ of Washington | |||||
Seattle, Washington, United States, 98104 |
Study Chair: | Marra CM | |
Study Chair: | Barker DE |
Haga clic aquí para ver información sobre este ensayo clínico en español. 
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Study ID Numbers: | ACTG 363 |
First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000945 |
Health Authority: | United States: Federal Government |
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