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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00000945
• Collaborator: (none)
• Enrollment: 24
• Locations: 19
• Patients Per Site: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Leukoencephalopathy, Progressive Multifocal	Drug: Cidofovir; Drug: Probenecid	N/A

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.

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• 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)
• Actual Study Completion Date: Mar 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	San Francisco AIDS Clinic / San Francisco Gen Hosp	San Francisco	California	United States	941102859
3	San Francisco Gen Hosp	San Francisco	California	United States	941102859
4	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
5	Howard Univ	Washington	District of Columbia	United States	20059
6	Northwestern Univ Med School	Chicago	Illinois	United States	60611
7	Cook County Hosp	Chicago	Illinois	United States	60612
8	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
9	Louis A Weiss Memorial Hosp	Chicago	Illinois	United States	60640
10	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
11	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
12	Beth Israel Med Ctr	New York	New York	United States	10003
13	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
14	Mount Sinai Med Ctr	New York	New York	United States	10029
15	Univ of Rochester Medical Center	Rochester	New York	United States	14642
16	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
17	Univ of Kentucky Lexington	Cincinnati	Ohio	United States	45267
18	Julio Arroyo	West Columbia	South Carolina	United States	29169
19	Univ of Washington	Seattle	Washington	United States	98104

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Marra CM,
• Study Chair: Barker DE,

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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..

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00000945
• Other Study ID Numbers: ACTG 363; 11327
• First Posted: Aug 31, 2001
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• 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
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; Leukoencephalopathy, Progressive Multifocal; Leukoencephalopathies; Cidofovir; Probenecid

Study Results

No Results Posted as of Oct 29, 2021