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NCT00000945 Clinical Trial

A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000945
Other study ID # ACTG 363
Secondary ID 11327
Status Completed
Phase N/A
First received
Last updated
Est. completion date March 2001

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 24
Est. completion date March 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cidofovir

• Probenecid

Locations
Country Name City State
United States Johns Hopkins Hosp Baltimore Maryland
United States Univ of Alabama at Birmingham Birmingham Alabama
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Cook County Hosp Chicago Illinois
United States Louis A Weiss Memorial Hosp Chicago Illinois
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Kentucky Lexington Cincinnati Ohio
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel 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 San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California
United States San Francisco Gen Hosp San Francisco California
United States Univ of Washington Seattle Washington
United States Howard Univ Washington District of Columbia
United States Julio Arroyo West Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: AIDS. 2003 Jan 24;17(2):281.. — View Citation

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