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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
This study has been completed.
First Received: November 2, 1999   Last Updated: July 29, 2008   History of Changes
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
  Purpose

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

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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000945

Locations
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
Sponsors and Collaborators
Investigators
Study Chair: Marra CM
Study Chair: Barker DE
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 363
Study First Received: November 2, 1999
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00000945     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Leukoencephalopathy, Progressive Multifocal
Probenecid
HIV-1
Central Nervous System Diseases
Acquired Immunodeficiency Syndrome
DNA, Viral
cidofovir
Anti-HIV Agents
Neurologic Examination
Renal Agents

Study placed in the following topic categories:
Cidofovir
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Demyelinating Diseases
Acquired Immunodeficiency Syndrome
Leukoencephalopathy, Progressive Multifocal
Central Nervous System Diseases
Polyomavirus Infections
Antiviral Agents
Immunologic Deficiency Syndromes
Encephalitis
Virus Diseases
Anti-Retroviral Agents
Radiation-Sensitizing Agents
Progressive Multifocal Leukoencephalopathy
Central Nervous System Infections
HIV Infections
Sexually Transmitted Diseases
Probenecid
DNA Virus Infections
Antirheumatic Agents
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Polyomavirus Infections
Central Nervous System Viral Diseases
Renal Agents
Infection
Gout Suppressants
Encephalitis, Viral
Anti-Retroviral Agents
Therapeutic Uses
Probenecid
Retroviridae Infections
Cidofovir
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Demyelinating Diseases
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Leukoencephalopathy, Progressive Multifocal
Central Nervous System Diseases
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Encephalitis
Virus Diseases
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 02, 2009