A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Endpoint Classification: Safety Study 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) |
| Estimated Enrollment: | 24 |
| Study Completion Date: | March 2001 |
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 |
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| 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 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| 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 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| 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 | |
| Study Chair: | Marra CM | |
| Study Chair: | Barker DE |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000945 History of Changes |
| Other Study ID Numbers: | ACTG 363, 11327 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 16, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Leukoencephalopathy, Progressive Multifocal Leukoencephalopathies Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Encephalitis, Viral Encephalitis |
Central Nervous System Viral Diseases Polyomavirus Infections DNA Virus Infections Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Demyelinating Diseases Probenecid Cidofovir Uricosuric Agents Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013
