A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients
NCT ID: NCT00000945
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2001-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cidofovir
Probenecid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marra CM
Role: STUDY_CHAIR
Barker DE
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of Alabama at Birmingham
Birmingham, Alabama, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Howard Univ
Washington D.C., District of Columbia, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11327
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 363
Identifier Type: -
Identifier Source: org_study_id