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A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients Clinical research trials and A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients. A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients clinical trial. Subjects frequently get the best healthcare possible for their A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients
A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients
For Condition: HIV Infections,Leukoencephalopathy, Progressive Multifocal
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
MarraCM, Study Chair,
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington
Seattle, Washington, 98104
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG 363;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000945
Other Leukoencephalopathy, Progressive Multifocal Studies:
1. A Study of Ro 24-7429 in Patients with HIV-Related Kaposi's Sarcoma
2. Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients with AIDS Who Have Not Had Success with Acyclovir
3. Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
4. A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
5. Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults
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A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients
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