A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients
- Conditions
- HIV InfectionsLeukoencephalopathy, Progressive Multifocal
- Registration Number
- NCT00000945
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Louis A Weiss Memorial Hosp
🇺🇸Chicago, Illinois, 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