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)
2 other identifiers
interventional
24
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
Marra CM, Rajicic N, Barker DE, Cohen BA, Clifford D, Donovan Post MJ, Ruiz A, Bowen BC, Huang ML, Queen-Baker J, Andersen J, Kelly S, Shriver S; Adult AIDS Clinical Trials Group 363 Team. A pilot study of cidofovir for progressive multifocal leukoencephalopathy in AIDS. AIDS. 2002 Sep 6;16(13):1791-7. doi: 10.1097/00002030-200209060-00012.
PMID: 12218391BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marra CM
- STUDY CHAIR
Barker DE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
March 1, 2001
Last Updated
October 29, 2021
Record last verified: 2021-10